ML20214V263

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Amend 20 to License SNM-1156 for Medtronic,Inc,Amending License in Entirety
ML20214V263
Person / Time
Site: 07001209
Issue date: 08/11/1986
From: Mccann G
NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III)
To:
Shared Package
ML20197E336 List:
References
NUDOCS 8610020218
Download: ML20214V263 (3)
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,i NZC Form 374______ m ._____. - .. _ __.____________________

NE 1 OF 3 NES !n i

4 (S-a4 U.S. NUCLEAR REGULATSF.Y COMMISSION Amendment No. 20 f MATERIALS LICENSE l f Pursuant to the Atomic Energy Act of 1954,~as amended, the Energy Reorganization Act of 1974 (Public Law 93-438). and ,

y iCode of Federal Regulations, Chapter I, Parts 30,31,32,33,34,35,40 and 70, and in reliance on statements and representations y 1 heretofore made by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byproduct, p 1 source, and special nuclear material designated below; to use such material for the purpose (s) and at the place (s) designated below to ll i

N k{ license delivershallorbetransfer deemed tosuch containmaterial the conditions tospecified persons in Sectionauthorized 183 of theto receive Atomic EnergyitAct inofaccordance with 1954, as amended, andthe is iregulations o

{f conditions subject tobelow.-

specified all applicable rules, regulations and orders of the Nuclear Regu In accordance with letter dated il June 26, 1985 !I 1 j

i 1. Medtronic, Inc 3. Ucense number SNM-1156 is amended in its entirety to read as follows:

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12. 7000 Central Avenue N.E. 1 N

3 1l Minneapolis, MN 55432 4. Expiration date August 31, 1991

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1! 5. Docket or
f 070-01209 N!

Reference No. p

1 6. Byproduct, source, and/or 7. Chemical and/or physical 8. Maximum amount that licensee

); special nuclear material form may possess at any one time -

under this license

% 6. Byproduct, source, 7. Chemical and/or 8. Maximum amount that 3 and/or special nuclear physical form licensee may possess '

jj material at any one time under this license 1

1 A. Plutonium (Principal A.SealedSource(s) A. 125 grams total, '

radionuclide Pu-238) (Alcatel-Gipsie) no single source l K@ to exceed 1 gram ,

Pu-238 l

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f 9. Authorized Use  !

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[ A. Recovery, analysis and storage of explanted nuclear pacemakers. l d i

-1 CONDITIONS i 4  !

4 10. A. Licensed material may be used at the licensee's Rice Creek Facility, 7000 d Central Avenue, Minneapolis, MN and at the licensee's Research Facility, y 1500 Northdale Boulevard, Minneapolis, Minnesota.  ;

d d B. The licensee is authorized to store one (1) Medtronic Model 9000 isotopic pulse i H generator at each of the licensee's seven district offices in accordance with  !-

1 letters dated September 8, 1977, September 27, 1977 and June 26, 1985. Storage i 3 at district offices shall not exceed 30 days.

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W q 11. Licensed material shall be used by or under the supervision of, individuals 4 designated by the licensee's Radiation Safety Committee, Thomas Hawkinson, Chairman.  ;

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q i d I 8610020218 860811 REG 3 LIC70 -

SNM-1156 PDR. ik I

, COPY

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NRC Form 374A U.S. NUCLEAR REIULATcHY COMMISSION PAGE OF P8GES Lic:nse number 6 i MATERIALS LICENSE ' '*

SUPPLEMENTARY SHEET 0 -01209  !.

Amendment No. 20  :

12. A. (1) The source (s) specified in Item (s) 7.A. shall be tested for leakage and/or [

contamination at intervals not to exceed 6 months. Any source received from another person which is not accompanied by a certificate indicating t that a test was perforrJed within 6 months before the transfer shall not be i

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put into use until tested.

(2) Notwithstanding the periodic leak test required by this condition, any licensed sealed source is exempt from such leak tests when the source contains 100 microcuries or less of beta and/or gamma emitting material or 10 microcuries or less of alpha emitting material.

(3) Notwithstanding the other provisions of this leak test condition, leak tests are not required on: (1) pacemakers ti.mplanted in experimental animals provided that a leak test shall be performed inmediately following removal of the pacemakers from the animals, and (2) on sealed sources containedin'pacemakersthathavebeensterilizedlancpackaged B. The test shall be capable of detecting the presence of 0.005 microcurie of l radioactive material on the test sample. If the test reveals the presence of  :

0.005 microcurie or more of removable contamination, the source shall be removed  ;

from service and decontaminated, repaired, or disposed of in accordance with Comission regulations. A report shall be filed within 5 days of the date the leak test result is known with the U.S. Nuclear Regulatory Commission, l Region III, 799 Roosevelt Road, Glen Ellyn, Illinois 60137, ATTN: Cnief, l l Nuclear Materials Safety and Safeguards Branch. The report shall specify the  ;

l source involved, the test results, and corrective action taken. Records of leak  :

l test results shall be kept in units of microcuries and shall be maintained for inspection by the Commission. Records may be disposed of following Commission '

inspection.

C. Tests for leakage and/or contamination shall be performed by the licensee or by other persons specifically licensed by the Comission or an Agreement State to perform such services.

13. Sealed sources containing licensed material shall not be opened.
14. The specified possession limit includes all licensed material possessed by the licensee under this license whether in storage, implanted in patients, or otherwise
in use.
15. Medtronic, Inc., shall collect, tally and report to the Nuclear Regulatory Commission, the data received from all investigators in accordance with the l ; procedures described in pages 2 and 3 of "Medtronic Laurens-Alcatel Model 9000 Isotopic Pulse Generator CLINICAL INVESTIGATION PLAh" dated March 21, 1973.
16. The licensee may transport licensed material in accordance with the provisions of 10 CFR Part 71, " Pac hging and Transportation of Radioactive Material".

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N7C Form 374A U.S. NUCLEAR RE!ULATcRY COMMISSION PAGE 3 o ,. 3 ,,ces I (s-42)

IJcense nurnber I SNM-1156 I MATERIALS LICENSE pocket or aeterence number I SUPPLEMENTARY SHEET 070-01209

!, l Amendment No. 20 I i

17. Except for plutonium contained in a medical device designed for individual human i application, no plutonium, regardless of form, shall be delivered to a carrier for shipment by air transport or transported in an aircraft by the licensee l except in packages the design of which the NRC has specifically approved for i transport of plutonium by air. I i
18. Except as specifically provided otherwise in this license, the licensee shall I conduct its program in accordance with the statements, representations, and procedures contained in the documents including any enclosures, listed below, l i

The Nuclear Regulatory Commission's regulations shall govern unless the statements, i representations and procedures in the licensee's application and correspondence are I more restrictive than the regul tions. I I

A. Applicatji dated Au' gust , 1969 and supplements dated May , 1970, l October 26,19J0,'May 1, p971, Augustt4'8,,1971, September , 1971, i Febrydry 28 V1972, Augustv29, 1972, Marc)v5, 1973, March 2 1973, Mayv10,1973, Septemberiff,197j4, Marchv24,1975, Apr)lV8,1976, October 7,1976, f  ;

1 FebruaryJ10, 1977, Septemberv8, 1977 and Septemberv27, 1977; I B. Application dated September , 1979; I C. Letters dated October 2, 1979, November 1, 1980 and March 8, 1982; and  !

D. Letters dated June./T6,1985 (Renewal) and Mayl21,1986. 1 E

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For the U.S. Nuclear Regulatory Commission b P

5 Original Signed E AUb I I 1986 Date By George M. McCann b Materials Licensing Section, Region III COPY (y

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