ML20215B292
| ML20215B292 | |
| Person / Time | |
|---|---|
| Site: | 07001342 |
| Issue date: | 08/21/1986 |
| From: | Johansen J NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I) |
| To: | |
| Shared Package | |
| ML20215B294 | List: |
| References | |
| NUDOCS 8610060485 | |
| Download: ML20215B292 (3) | |
Text
7mmmmmmmmmmmmmmLmmmmmmm---mmmmmmm---mmmm-T NRC Form 374 g
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.S. NUCLEAR REIULATORY COMMISSlHN MATERIALS LICENSE Amendment No. 20 l
Pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93-438), and Title 10, 3
Code of Federal Regulations, Chapter I, Parts 30,31,32,33,34,35,40 and 70, and in reliance on statements and representations y
T heretofore made by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byprcduct, l
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source, and special nuclear material designated below; to use such material for the purpose (s)and at the place (s) designated below;to
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1 deliver or transfer such material to persons authorized to receive it in accordance with the regulations of the applicable Part(s). This i
J license shall be deemed to contain the conditions specified in Section 183 of the Atomic Energy Act of 1954, as amended, and is I
subject to all applicable rules, regulations and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any conditions specified below.
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Licensee I
1 In accordance with letter dated I
j July 10, 1986 f
j Coratomic, Inc.
- 3. License number SNM-1319 is amended in
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its entirety to read as follows:
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- 2. P.O. Box 434 C'
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f Indiana, Pennsylvania 6
15701
- 4. Expiration'date September 30, 1990 j
- 5. Docket or
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Reference No.
070-01342 g
1l 6. Byproduct, source, and/or
- 7. Chemical and/or physical
- 8. Maximum amount that licensee E'
31 special nuclear material form
? may possess at any one time I
,under this license i
A. Not to exceed 250 I
A. Plutonium (Principal A. Sealed sources
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radionuclide Pu-238)
(Plutonium batteries) mil,ligrams of Pu-238 per l
1 i-seale'd source; 290 grams g.
B. Plutonium 238 B. Se$leb utron source
'B.
73 curies 1
(Monsanto)
(275 milligrams)
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Authorized use c.
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(1) For use as a component in assembled Coratomic Model C;101 pacemakers and as a r
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component in the assembly (manufacturing) of Coratomic Model C-101-P I:
l pacemakers; for distribution to medical institutions authorized to receive E
f pacemakers pursuant to the terms and conditions of a specific license issued l
g by the Nuclear Regulatory Commission or-an Agreement State.
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(2) For recovery as a component of explanted Coratomic Model C-100, C-101 and g-1 C-101-P pacemakers transferred from specific licensees.
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(3) For storage or disassembly and re-furbishing of the battery source from l
j Coratomic Model C-100, C-101 and C-101-P pacemakers.
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For use as a calibration source.
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CONDITIONS lE I
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- 10. Licensed material shall be used only at the licensee's facilities, 300 Indian j
Spring Road, Indiana, Pennsylvania.
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i-1 11. Licensed material shall be used by, or under the supervision of, individuals who i
J have completed the training program as outlined in the letter dated August 19, 1985 E
f, and have been designated by Frederick J. Shipko, Radiation Safety Officer.
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hI 8610060485 860021 SNitW='9sgsrafust NI.t[0 h mmmaus:xmmaus2 Pna
,__________________________________________________-- 4
, NRC Form 374A U.S. NUCLEAR RE;ULATICM COMMISSION 2
3 l
- oAGE og paces Licen,e number I
MATERIALS LICENSE pocket or aeterence nu SUPPLEMENTARY SHEET 070-01342 Amendment No. 20 (continued)
CONDITIONS l
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- 12. As six month intervals Coratomic, Inc. shall collect and tally data from all medical institutions with respect to:
(a) accountability, removal and recovery, k
(b) duration of satisfactory performance or the time of service before malfunction, and (c) nature of malfunction (if appropriate) of all implanted Coratomic Model C-100, C-101, and C-101P nuclear-powered pacemakers. Within ninety (90) days I
of the six month period ending February 28 or August 31, one copy of the report f
shall be sent to the U.S. Nuclear Regulatory Comission, Division of Fuel Cycle and t
Material Safety, Material 1icensing Branch,leaq Regulatory Comission, Region I, Washington, D.C.
20555. A second copy t
of the report shall be sent to the U.3. (Nuc t
Nuclear Materials Safety SectionI631 Park ~Avsnue/, King of Prussia, Pennsylvania i
19406.
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- 13. Coratomic, Inc., shall maintain records of the medical institutions approved by the g
FDA for participation in IDE G 810104/A2 and the date of FDA's approval of each
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institution.
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- 14. This licensed does not authorize the imolantation of-pacemakers.into humans or I
f animals.
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A(1)Anysealedsourcesordetectorcellssp)eci(fied.inItems7;iexceed6 months.
15.
A amd 7.B shall be t
testedfor}1eakage$nd/or'contadiinitT6n t intervals.not t L
Any source or, detector cell' received 'from another: person wtiich is not I
accompaniedby a ce"rtificaterindicating!that a test was performed within I
6 months before the : transfer.shallinot:be.put into use until tested.
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(2)Notwithstand g the periodic'l'eakle'st r'ehired by this~ condition, any f
licensed sealed source or detector cell ;is; exempt from:such leak tests
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when the source or,in~g material or*10'microcuries of.less of alpha emitting detector cell. contains 100 microcuries or less of beta F
and/or gamma emitt I
material.
l AnysealedsourceordetektorM' ell /inskora C
B.
and not being used need
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When the source or# ete"ctor cell is removed from storage t
l not be tested.
d for use or transfer to another person, it shall be tested before use or transfer.
C.
The test shall be capable of detecting the presence of 0.005 microcurie
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of radioactive material on the test sample.
If the test reveals the t
presence of 0.005 microcurie or more of removable contamination, the i
source or detector cell shall be removed from service and decontaminated, repaired, or disposed of in accordance with Comission regulations. A l
report shall be filed within 5 days of the date the leak test result is known with the U.S. Nuclear Regulatory Comission, Region I, ATTN:
- Chief, g
Nuclear Materials Safety and Safeguards Branch, 631 Park Avenue, King of y
Prussia, Pennsylvania 19406. The report shall specify the source involved, p
the test results, and corrective action taken.
Records of leak test i
results shall be kept in units of microcuries and shall be maintained for I
inspection by the Comission. Records may be disposed of following l
Comission inspection.
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U.S. NUC L R RE!Ut.ARRY COMMISSION p onnsnA
^ PAGE 3
3 PAGES or License zumber,
g,,,,,,,,,,,,,,,,,,[,,rM MATERIALS LICENSE I
SUPPLEMENTARY SHEET R
070-01342 y
f Amendment No. 20 l
(15. continued)
CONDITIONS N
D.
Tests for leakage and/or contamination shall be performed by the licensee y
or by other persons specifically licensed by the Commission or an Agree-p ment State to perform such services.
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- 16. The licensee may transport licensed material in accordance with the provisions of 10 CFR Part 71, " Packaging and Transportation of Radioactive Material".
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- 17. The licensee shall conduct a physical inventory every 6 months to account for all sources and/or devices receiyediand! possessed under the license.
Records of inventories shall be maintained fo'r 2 yeirir'from/the date of each inventory.
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- 18. Except as specifically provided otherwise in this license, the licensee shall y
conduct its program in accordance with the statements, representations, and y
procedures contained in the documents including any enclosures, listed below.
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The Nuclear Regulatory Commission's regulations shall govern unless the state-p ments, representations and procedures in the licensee's application and corre-E spondence are more restrictive than the. regulations.
l A.
Application dated May 2 -1985 i 'i.
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B.
Letter dated' August 19,_1985 C.
July 10, 1986
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l For the U.S. Nuclear Regulatory Commission p
Originsi Signed By:
l Date AUG 211986 By l
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Nuclear Materials Safety and Safeguards Branch, Region I p
King of Prussia, Pennsylvania 19406
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