ML20141J711
| ML20141J711 | |
| Person / Time | |
|---|---|
| Issue date: | 08/15/1997 |
| From: | Michele Burgess, John Lubinski NRC |
| To: | |
| Shared Package | |
| ML20141J616 | List: |
| References | |
| SSD, NUDOCS 9708210105 | |
| Download: ML20141J711 (11) | |
Text
._
REGISTRY-OF RADIOACTIVE SEALED SOURCES AND DE! ICES SAFETY EVALUATION OF SEALED SOURCE (Amended in its Entirety)
No.:
NR-187-S-101-S DATE:
August 15,1997 PAGE 1 OF 8 SOURCE TYPE:
Brachytherapy Seed Source MODEL:
81-01 MANUFACTURER / DISTRIBUTOR:
Best Industries 7643 Fullerton Rd.
Springfield, VA 22153 ISCTOPE:
MAXIMUM ACTIVITY:
Iridium-192 100 millicuries (1.48 GBq)
LEAK TEST FREOUENCY:
6 months PRINCIPAL USE:
(t) General Medical Use CUSTOM SOURCE:
YES.
x NO 9708210105 970723 PDR RC SSD PDR
6 REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES.
SAFETY EVALUATION'OF SEALED SOURCE (Amended in its--Entirety)
No.:
NR-187-S-101-S DATE: ' August' 15,1997 PAGE 2 OF 8 SOURCE-TYPE:
~ Brachytherapy Seed Source DESCRIPTION:
Best-Industries claims that the Model 81-01 sources are identical in. design and construction to RAD / IRID, Inc., Model R/l sources and other sources which have been in use since 1960.
Each-seed
!contains Iridium 30% - Platinum 70% alloy source material in the form of a wire doubly encapsulated in Type 304 stainless steel.
The capsules are cold welded at.each end (machine crimped) to-a nominal length of 0.13 inches (3 mm).
Nominal outer diameter for the Iridium / Platinum wire is 0.003 inches (0.076 mm).
Nominal-j outer diameter of the-inner _ stainless steel capsule is 0.012 inches (0.305 mm) with-a nominal thickness of 0.0085 inches
- (0.216 mm).
Nominal outer diameter of-the outer stainless steel capsule is 0.020 inches (0.508 mm) with a nominal thickness of
- 0. 007 inches - (0.178 mm).
Following batch irradiation in a reactor, the completed seeds are forced into nylon ribbons which have an inner diameter less than the outer diameter.of the sources _in order to prevent movement.
Spacing of the sources along the ribbon is typically 0.4 inches (1 cm) center to center, however, up to 3 seeds per centimeter can-be accommodated.
Each ribbon will.be supplied with approximately 39.4 inches (100 cm) of inactive leader at one end to facilitate handling and about 1.2 inches (3 cm)Lon the other.
Seeds and ribbons _are supplied in sets.
A standard set consists of 14 ribbans containing 12 seeds each with I cm spacing.
Ribbons can be customized with up to 7.9 inches (20 cm) of active length according to user specifications.
The most commonly
-suppliedcactivity is 10 millicuries per seed.
DIAGRAM:
I See attachments 1 and'2.-
. ~..
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY; EVALUATION.OP SEALED SOURCE z
(Amended in11ts Entirety)
No.:~ NR-187-S-101-S DATE: -August-15,1997 PAGE 3 QE_H SOURCE TYPE:
Brachytherapy Seed Source LABELING:
Because of their small size, individual seeds and ribbons are not 4
labeled but rather, each shipping container will be labeled.
Additionally, ribbons may be color coded to designate various activity levels as of the date of shj pment.
However, color selection is not dependent upon a specific activity level.
Seeds in ribbons are supplied as a set with the activity of each ribbon within a range as Specified by the end user.
The shipping containers for each set bear labels containing the following:
" CAUTION - RADIOACTIVE MATERIAL" Radiation Symbol, Isotope, Amount, Date Best Industries, Inc.
7643-B Fullerton Road Springfield, VA 22153 Ship To:
Date of Shipment P.O. Number Activity on Date of
- of Ribbons
- of Seeds Shioment (ma Raea)
Code' Color" a
4 Internal code to identify reactor irradiated batch of Note:
- seeds.
Ribbonc may be color coded to designate the activity on date of shipment (milligram radium equivalent).
Typical colors used are white, red, or blue.
For seeds above 11 mci (0.407 GBq) the following label will be added:
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALEL SOURCE (Amended in its Entilety)
No.:
NR-187-S-101-S DATE:
August 15,1997 PAGE 4 OF 8 SOURCE TYPE:
Brachytherapy Seed Source LADELING (con't):
4 CAUTION:
These Iridium-192 seeds are considered high activity sources because of the high dose rate.
The dose rate per mci of Iridium-192 seeds at 1 cm is 4.6 R/hr.
At 5 cm the dose rate is 184 mR/hr.
At 30 cm the dose rate is 5.1 mR/hr and at 100 cm it is 0.46 mR/hr.
Use extra care and follow all instructions included in the bill of lading.
CONDITIONS OF NORMAL USE:
The seeds in ribbons are designed for use in hospital or clinical environments for the interstitial or intracavitary treatment of cancerous tumors.
The sources are designed to withstand autoclave or steam sterilization temperatures up to 270*F (132 C) and pressures up to 15 psi (103 kPa) for up to 10 minutes.
However, ethylene gas sterilization methods using temperatures between 120'F (49 C) and 140 F (60 C) are recommended.
The sources shall not be subjected to dry heat sterilization.
PROTOTYPE TESTING:
Prototype testing of the sources.has not been performed by Best Industries, Inc., due to the fact that essentially identical sources have been manufactured and in use since 1960.
The manufacturer has stated that the sources are identical in size and construction to RAD / IRID Model R/1 sources and that neither Best Industries, Inc. nor RAD / IRID have encountered any problems with the sources in clinical practice.
RAD / IRID sources have been subjected to the following tests:
Exposed to water and cold and-warm isotonic saline solutions (0.25 percent sodium chloride by weight) for periods up to six months without signs of corrosion or deterioration.
Prolonged exposure to concentrated "aepherin" (antiseptic solution) of up to six months without signs of corrosion or deterioration.
l REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED. SOURCE (Amended in its Entirety)
-l No. :.
NR-187-S-101-S DATE:
August 15,1997 PAGE 5 OF 8 SOURCE TYPE:
Brachytherapy Seed Source EBOTOTYPE TESTING fcon't):
Sources were autoclaved at pressures up to 350 psi and temperatures up to 250 F for 30 minute periods without any adverse effects noted.
EXTERNAL RADIATION LEVELS:
External radiation levels for a 10 mci (0.37 GBq) source are as follows:
Distance from Ir-192 Measured radiation levels source Seed Activity (mrem /hr)
(mSv/hr) 5 cm (1.97 in) 10 mci (0.37 GBq) 1840.0 18.4 30 cm (11.81'in) 10 mci (0.37 GBq) 51.0 0.51 OUALITY ASSURANCE AND CONTROL:
Best Industries, Inc., states that quality assurance and control are provided routinely throughout the manufacture and use of the sources.
The stainless steel tubing from which the capsules are made is certified by the manufacturer to be type 304 stainless j
steel hypodermic needle-tubing with chemical composition and mechanical properties tested and notarized.
The manufacturer of the Iridium / Platinum wire (Englehard Industries) certifies it to be an alloy-of 30 percent iridium and 70 percent platinum.
During seed fabrication, representative numbers are individually inspected with a magnifying glass to ensure the integrity of the cold weld when fabrication is complete.
All seeds are individually inspected for uniformity and bent or damaged seeds are discarded.
After seeds are
~
irradiated, they are comparatively measured.with a standard of known activity.
Representative seeds are then smear tested for possible contamination.
4 a
REGISTRY?OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE-(Amended in its Entirety)
No.:
NR-187-s-101-S DATE: _ August 15,1997 PAGE 6 OP.8 SOURCE TYPE:
Orachytherapy Seed Source OUALITY ASSURANCE AND CONTROL (con'ti-All-Model 81-01, iridium-192 sources and ribbons are calibrated to millicuries using a calibrator which has been standardized by the National Institute of Standards and Technology (NisT).
A
- specific Gamma Ray Constant of 4.6 R cm hr mCid is used for 2
d
- converting millicurie values into milligram radium equivalent.
Best Industries further states that their rigid quality control program insures that iridium seeds are produced with close tolerances and that they are uniform in their activity.
All assembled ribbons are calibrated before shipping and no ribbon is sent to customers if it varies more than 15 percent from the stated average activity.
The factor used for the conversion of millicuries of iridium-192 to milligram radium equivalent is 0.56, assuming a specific Gamma Ray Constant of 8.25 R cm hr mci" for radium-226.
Each batch of 2
d
- seeds is given a code number for traceability and ribbons are smear tested for contamination to an acceptance limit of 10-6 microcurie / ribbon.
LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:
- The Model 81-01 source shall be manufactured and distributed according to.the requirements of Section 32.74, 10 CFR Part 32 and distributed only to persons specifically licensed by the NRC or an Agreement State.
- The_ sources shall not be exposed to concentrated acids or alkaline fluids or sterilized by dry heat methods.
The sources shall not be exposed to autoclave pressures in excess of-15 psi (103.4 kPa) and temperatures in excess of 270*F (132.2*C), nor to these temperatures and pressures for periods in excess of 10 minutes.
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (Amended in its Entirety)
No.:
NR-187-S-101-S DATE:
August 15,1997 PAGE 7 OF 8
\\
SOURCE TYPE:
Brachytherapy Seed Source l
LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE (con't):
The soutees shall not be autoclaved in plastic tubing or l
plastic containers (only autoclave suitable material such as stainless steel, glass, nylon, teflon, lead or tin should be used).
f The sources shall be leak tested at intervals not to exceed six months using techniques capable of detecting l
0.005 microcurie (185 Bq) of removable contamination.
l l
REVIEWER NOTE:
Please ensure the safety procedures outlined l
in 10 CPR Part _ 35 Subpart G are adhered to, especially as they pertain to the handling of the sources.
Specifically, ribbons should be used only in closed end catheters or completely closed outer catheters to prevent direct contact with tissue.
This registration sheet and the information contained within the references shall not be changed without the written consent of the NRC.
Handling, storage, use, transfer, and disposal:
To be determined by the licensing authority.
The sources shall be handled only with appropriate equipment (due to the high activity of the sources forceps are recommended).
SAFETY ANALYSIS
SUMMARY
Based on our review of the information and test-data cited below and the past history of similar source designs, we continue to conclude that the Best Industries, Inc., Model 81-01 sealed sources ure acceptable for-licensing purposes.
-Furthermore, we continue to conclude that these sources would ce expected to maintain their containment integrity for normal and accidental conditions of use which might occur during the uses I
specified in this registration sheet.
l
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (Amended in its Entirety)
No.:
NR-187-S-101-S DATE:
August 15, 1997 PAGE 8 OF 8 SOURCE TYPE:
Brachytherapy Seed Source l
EEFERENCES:
The following supporting documents for the Best Industries, Inc.,
Model 81-01 sealed source are horeby incorporated by reference and are made a part of this registry document.
Best Industries, Inc., application dated July 24, 1981.
Best Industries, Inc., letters dated September 3,
- 1981, July 26, 1984, January 15, 1992, April 14, 1992, and July 23, 1997, and enclosures thereto.
ISSUING AGENCY:
/
U.S.
Nuclear Regulatory Commission
/
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Date:
Aucust 15. 1997 Reviewer:
'/
/ John Lubinski Date:
Auaust 15, 1997 Concurrence: '#e/d Michele Burgess"
~
REGISTRY OF RADIOACTIVE SEALED SOURCES AND-DEVICES SAFETY. EVALUATION OF SEALED-SOURCE (Amended in its Entirety)
No.:.NR-187-S-101-S DATE:
August 15, 1997 ATTACHMENTl 3-2 3-3 3-1 2.0005 I D' 3-2.ooi 00.0200 c0.0035
't y
_"_ Awev&wweE'4AWwe55 py w w w w m w w w w m w w w]
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. ooi 00.013 20.005 0.130 I.D 3-3 Note:
Both ends are crimped 3-3 TUBE 0.D. e0.020 S.S. 304 3-2 TUBE 0.D. e0.012 S.S. 304 3-1 VIRE 0.D. 00.003 Pt - Ir NO.
DESCRIPTION MATERIAL d
REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF SEALED SOURCE (Amended in its Entirety) 1 ILh1 NR-187-S-101-S DATE:
August 15, 1997 ATTACHMENT 2 l
l-l Figure shows cae nylon ribbon loaded u
with 12 itIdino-192 seeds spaced 1 cm apart from *.he center of one seed to another.
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- NOTE T0:
SSD FILE -- NR-0187-S-101-S DATE:
8/15/97 RE:
BEST INDUSTRIES. INC.
LETTER DATED JULY 23, 1997
. Spoke with Mr. Roman from Best Industries on July 14.-1997. regarding the increase in activity.
He stated that everthing else for the Model 81-01 would i
be exactly the same and if they were to make changes, they would notify NRC.
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Ms. Michele L Burgess, Technical Resiewer Source Containment & Devices Brar.ch U.S. Nuclear Regulatory Commission -
Dnision ofIndustrial and Medical Nuclear Safety 4
Office of Nuclear Materials Safety & Safeguards
!1555 Rockville Pike
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Jaly 23,1997 l
Mr. Steve Baggett, Section Leader VIA FACSIMILE y
Office of Nuclear Materials Safety and Safeguards U.S. Nuclear Regulatory Commission 11555 Rockville Pike 4
Rockville, MD 20852 j
Dear Mr. Baggett:
Pursuant to my discussions with you yesterday, this is to request an amend to our SSD-registration certificate no. NR-187-S-101-S, dated June 24,- 1992 to increase the activity per Iridium-192 seed-to 100 mci. I am enclosing the first page of the registration-certificate for your reference.
We currently have Iridium-192 sources on hand which are approximately 40 mci per seed.
We would like to know whether we can get a verbal approval to ship these sources for the on-going clinical trials at the Washington Hospital Center under their broad license.
Please feel free to contact me at 800/336-4970 if you have any questions.
With kind regards,
-1 4
Krishnan Suthanthiran President KS/gd Enclosure (f
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- 7643 Fullerton Road. Springfield, Virginia 22153
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4 REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES
-SAFETY EVALUATION OF-SEALED SOURCE-(Amended in-its Entirety)
- HQ,:.NR-187-S-101-S DATE:
June 24, 1992 PAGE 1 OF 7
- SOURCE TYPE:
Brachytherapy seed Source MODEL:
81-01 l
l MANUFACTURER / DISTRIBUTOR:
Best Industries l
=7643 Fullerton-Rd.
l Springfield, VA-22153 l
i" ISOTOPE:
MAXIMUM ACTIVITY:
Iridium-192 33 millicuries (1.22 GBq)
LEAK-TEST FREOUENCY:
6 months PRINCIPAL USE:
(V) General-Medical Use t
CUSTOM SOURCE:
YES x
NO
e Nec FORM 577.
U.S. NUCLEAR REaULATO,4Y COMMISSION 6%
LICENSE FEE AND DEBT CG' *.ECTION BRANCH DIVISION OF ACCOUNTING AND FINANCE LICENSE FEE REQUIREMENTS OFFICE OF THE CONTROLLER U.S. NUCLEAR REGULATORY COMMISSION WASHINGTON. DC 20555 0001-.
TYPE OF ACTION NEW LICENSE RENEWAL OF LICENSE BEST Industries, Inc.
AMENDMENT TO LICENSE ATTN: Mr. Krishnan Suthanthirari Pres. dent REOUESTED DATE i
7643 Fullerton Road '
7-23-97 Springfield,VA 22153 LICENSE UUMBER NR 187-S-101 S CONTROL NUMBER 9' 52
^
- l. APPLICATION FEE DUE
- 11. FEE NOT REOUIRED Your r: quest for a hcensing action is sub ect to tne fee (s) in the i
category (ies) noted below in accordance with Section 170.31 of the Enclosed is Check No.
which accompanied your Enclosed Federal Register notice. Payment of the fee is required prior to request. The fee is not req'uired because:
the issuance of the hcense renewal. or amendment.
We received your Check db - APPLICATION RENEWAL
_ AMENDMENT
- No.
sn payment of 9C
~5
's "s
630.00 the fee.
s s
's s
s s
The Licensing staff has informed us that your request is to be considered as a continustion of your request dated s
S S
, Control No.
s s
s I
- 3 3
Your request was combined, pnor to review, with your -
8 8
8 request. Control s
s s
No.
S s
s lit. CHECK RETURNED FEE (s) DUE s
630.00 hn(se[sdheck No, which was retumed to us PAYMENT RECEIVED s
0.00 AMOUNT DUE s
630.00 INSUFFICIENT FUNDS
' ' Your request was received without the "esenbed apphcation fee.
ACCOUNT CLOSED
- We received your Check OTHER No.
In the amount of Payment of the additional fee noted above is required.
Your request Yllincrease the scope of your heense pro MAIL THE REPLACEMENT CHECK TO mE ADDRESS LISTED AT THE Therefore, your reouest is subject to the apphcation fee (gram.
TOP OF THIS FORM AND REFERENCE THE ABOVE CONTROL s) noted NUMBER.
above. Refer to Section 170 31 and Footnote 1(d)(2).
IV. LICENSE ISSUED WITHOUT THE REOUIRED FEE Your heense expired poor to the receipt of your apphcation for Ucense
. Amendmed renewal. Therefore, your request is subject to the application fee (s)
No Ni
, issued on noted above. Refer to Section 170J1 und Footnote 1(a)-
was issued without the required fee being collected. The fee required is noted in Section I of th:s MAKE PAYMENT OF THE FEE (S)D Mall THE PAYMENT TO THE Nscope of your hcensed program was increased Thersfore, your TO THE U S NUCLEAR REGULATORY COMMISSIO*? AN request is subject to the apphcation fee (s) noted in Section 1 of this ADDRESS LISTED AT THE vP OF THIS FORM IF WE DO NOT RECEIVE A REPLY FROM YOU WITHIN 30 CALENDAR DAYS FROM form Refer to Section 170 31 and Footnote 1(d)(2)
THE DATE LISTED BELOW. WE SHALL ASSUME THAT YOU DO NOT WISH TO PURSUE YOUR APPLICATION AND WILL VOID THIS -
Because of the urgency of your request, the hcense was issu=!.
ACTION.
without remittance of the pres.cnbed fee noted in Section 1 of this form.
StGNATURE - UCENSE FEE ANALYST LFDCB LFDCB Distnbution:
DATE sik
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FAX oate:
7/23/97 7;me: j f f g,,,
Number ofPages (inc. cover):.3 FROM:
Best industties,Inc.
TO:
steve tassett, section Leader 7643 Fullerton Road Office of Nuclear Materials Safety Springfield, VA 22153
& safeguards U.S. N.R.C.
Rockville, MD SENT BY:
Krishnan Suthantlu.ran TITLE:
President REFElWNCE:
970723-h PHONE:
703-4514 ~1 EXT.104 PHONE:
301/415-7273 FAX:
703 451 6 77 FAX:
3olf415 5369
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The documents accompanying this telecopy transmission may contain enndential information belonging to the sender which is legally privileged. The informadou is intended only for the uses of indisidual or entity named above. If you are not the intended recipient, you are hereby nottfied that any disclosure, copying, distribution or the taking of any aedon in reliance on the contents of this telecopied information is strictly prohibited. If you have received this telecopy in error, please immediately notify us by telephone to anange for reture of the original documents to us.
REMARKS: O Urgent O Review 0 Reply ASAP O Comment IF YOU DO NOT RECEIVE ALL PAGES. PLEASE CALL
'C AT 703-451-2378, Ext.
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Number ofPages (inc. cover): J FROM:
Best Industries, Inc.
TO:
steve saggett, section 1,eader 7643 Fullerton Road Office of Nuclear Mat erials Safety Springfield, VA 22153
& safeguards U.S. N.R.C.
Rockville, MD l
SENT BY:
Krishnan Suthantlu.ran TITLE:
President
REFERENCE:
970723-h PHONE:
703-451-2378 EXT,104 PIIONE:
301/u s-7273 i
~ FAX:
703 451-4977 FAX:
301/415-5369 The documents accompanying this telecopy transmission may contain confidential information belonging to the sender which is legally privileged. The infortnation is intended only for the uses of individual or entity named above. If you are not the intended recipient, you are hereby notified that any disclosure, copying. distribution or the taking of any action in reliance on the contents of this telecopied information is strictly prohibited. If you have received this telecopy in error, please immediately notify us by telephone to arrange for rehirn of the original documents to us.
REMARKS: O Urgent O Review 0 Reply ASAP O Comment IF YOU DO NOT RECEIVE ALL PAGES. PLEASE CALL
~O AT 703 451-2378, Ext.
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~.. :yM2mO9 7643 Fullerton Road + Springfield,VA 22153 TO: Mr. Steve Baggett. Section Leader Office of Nuclear tbterials Safety & Safeguards U.S. Nuclear Regulatory Cor. mission 11555 Rockville Pike,
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- if$N?@hMY ga BEST MEDIC 6L INTERNRTIOMML Leader in innovative 7echnology and Endavascular Brachytherapy August 12,1997 Ms. Michele L. He gess, Technical Reviewer Source Containment & Devices Dranch U.S. Nuclear Regulatory Commission Division ofInJustrial and Medical Nuclear Safety Office of Nuclear Materials Safety & Safeguards 11555 Rockville Pike Rockville, MD 20852
Dear Ms. Burgess:
This is to inform you that Best recently entered into a partnership with Cordis Corporation, a Johnwn & Johnwn company, for research, development, regulatory i
approval, production, marketing and distribution of devices, radioisotopes, and systems for medical applications using intravascular radiation therapy.
This partnership will strengthen both companies' resources to enable us to explore the full potential of our pioneering efrorts using radiation to inhibit restenosis. Dest will be able to draw upon the enormous experience and expertise that the Cordis team has to expand this technology, Cordis has now assumed the responsibility for catheter development, clinical trials, study site selection and qualification, regulatory approval and marketing.
With kind regards, Krishnan Suthanthiran l' resident KS/gd Toh,
Q1-& htM %-2.fy 7
=,
17643 Fuperton Road. Springfield,VA 22153. USA. 8 703-4512378 800 336-4970. FAX:703-4515228 -
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