ML20212D974

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License SNM-1828 for Veterans Admin Hosp,Authorizing Use of 15 G Pu-238 Sealed Source for Implantation in Humans as Component of Nuclear Powered Pacemakers
ML20212D974
Person / Time
Site: 07002876
Issue date: 06/13/1978
From:
NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To:
Shared Package
ML20212D767 List:
References
NUDOCS 8608120597
Download: ML20212D974 (2)


Text

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, r ades" P ge 1 of 2 Pages U . NUCLEAR REGULATORY COMMlf JN MATERIALS LICENSE Y

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Pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93- f 438), and Title 10. Code of Federal Regulations Chapter 1. Parts 30, 31, 32, 33, 34, 35, 36, 40 and 70, and in reliance on statsments and representations heretofore made by the licensee, a license is hereby issued authorizing the licensee to rzezive, acquire, possess, and transfer byproduct, source', and special nuclear material designated below: to use such g mitsrial for the purpose (s) and at the place (s) designated below; to deliver or transfer such material to persons authorized j to receive it in accordance with the regulations of the applicable Part(s); and to import such byproduct and source metsrial. This license shall be deemed to contain the conditions specified in Section 183 of the Atomic Energy Act of 1951, i es amended, and is subject to all applicable rules, regulations and orders of the Nuclear Regulatory Commission now or hrresiter in effect and to any conditions specified below.

Licensee '

1. Veterans Administration Eospital
3. License number S?H-1828
2. 800 Poly Place h-M p, t 11209
4. Expiration date July 31, 1983 Docket or U10~UZUlb
5. Reference No. StN-1358, 070-01369
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

{

A. Plutonitra (Principal A. Sealed Source (s) A. 10.5 grams (50 individual '

radionuclide Fu-230) Ecurces not to exceed -

210 milligrams each)

B. Plutonitz (Principal B. Eealed Source (s) B. 15.0 grams (60 individual:

radionuclide Pu-238) sources not to exceed 250 milligrams each)

9. Authorized use  !

A. Dplantation in htmens as a ocuyonent of Medtronic Model 9000 nuclear-powered  !

cardiac paceraker for clinical evaluation purposes in accordan::e with "Medtronic j i Laurene-Alcatel Model 9000 Isotopic Pulse Generator Protam1," dated March 21, 1973. t

!  ?

P. Inplantation in htrans as a cor:ponent of Coratcutic Model C-101 nuclear-powered i pacerekers for clinical evaluation purposes in accordance with "INnan Clinical Protocol for the Coratoric C-101 Radioisotope Powered Cardiac Pacer," dated tiovtrter 1,1975. i 2

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1 8608120597 860728 REG 1 LIC70 SNM-1969 PDR l

Q7 %M NEC 370A I S. NUCLEAR REGULATORY COMMISSIOr Page of 2 Pages I

p MATERIALS LICENSE q Supplementary Sheet License Number f # ~ -II 2 '

  • f CG InICs Docket or 070-02876 Reference No.

Srn-1358, 070-01369

10. Licensed waterial shall be used only at the licensee's addrecc stated in Its 2 ateve.
11. We crecified r.cssession lir.it includec all licensed reterial possessed by the licensec under this license W ther in storage, inplanted in ratients er otherwise ir-use.
12. ne licensee chall nct receive er troncfer in cny single trensection,1 grar or rrore of clutonitr. 23e cortained in nucicar-romred pacc-akere scitteut notifTiry tLe i civision of Eafeguarde, U. S. Nuclear Fe<ralstory Corcicoicn, Iashington, D. C. 20555, I and, in addition, cmpletina and distritxting Forr 5TC-741 ac recuired 6/ Ecetice.

70.54 of 10 Cnt Part 70.

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13. Se licenree chell regert to the Fadioisotorec Licensing Eranch, U. S. Itclect Peculatory Cctriscion, Eashingtcm, D. C. 205SS, within 24 tcurr of occurrerce, the death of any r.uclear recomeker patient, and any Mverre reaction and/cr relfurcticn involving a racerater systm, inc1Ldire the leedc. A witten retort givirs c'etails cf the Mverre reacticn crd/or ralfmetion shall te sttrittcd within 30 dayc.
14. We licantee shall report to the Fadioirctests Licennir,3 trench, C.S. ruclear Pegulatcry Caricsion, itshirctcc, C. C. 205E5, within 10 days, Icre c.f cor. tact witr nuclear paccraker ratient.
15. We licontee troll centir.tm ectient fc]lct-or m/ repicccrent crecedures ict M-ruclear raccrater durire the life ci :be tcticrt; cre ;rccederte fcr rcccccry an cet'crizW dicrecc1 cf tre nteleer nac<rci er N retuu tc. trc *ar.uf tettrce rSc11 i c follc-:cd LTor the Geath cf the pctier.t.

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16. xce-t as gccifice.11y crevided othw.,ise by this licence, the licensee ria11 rossens ard ure licented raterial dercribed in Itcas 6, 7, and 8 of thic licence in acccrier.cc with statcrents, representations, and prccedurcs centained in the licerrca'r arvlicatice t.t Ich wc trcnrrittcd by letter frcr ! . Ciriterg, tirector, 'Jcted February 13, 1973; in aenchents to the acplication centained in letters fren Vicent A. P!ccerc, Jr., ".c., dated Artil 23, 1973 art Fay 3,1973; in arerCrent to tFc E icaticn l contained in letter sicrrd by I.!. Cinrterc, P.D., and Vincent .T..

bicccre, Jr. , t .n. , dated July 15, 1975; and Ictter dated Mcy 30, 1978.

For the U S.pucgargulgt9ty Commission m r,v ~

JUL 131978 radjeirctorce Licencing Trarch Date. by

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Dmsion of Materials and Fuel Cycle Facility Licensing Washington, D. C. 20555