ML20205R990
| ML20205R990 | |
| Person / Time | |
|---|---|
| Site: | 07002199 |
| Issue date: | 03/30/1987 |
| From: | Glenn J NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I) |
| To: | |
| Shared Package | |
| ML20205R996 | List: |
| References | |
| NUDOCS 8704060500 | |
| Download: ML20205R990 (2) | |
Text
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gl' q (SfeRC 84 Form 374 U.S. NUCLEA3 CE ULATZY COMMIS$10N 1 ~U '9
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(; MATERIALS LICENSE Amendment No. 09 g Pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93 -438), and Title 10. N i
g Code of Federal Regulations, Chapter I, Parts 30,31,32,33,34,35,40 and 70, and in rehance on statements and representations {
(! heretofore made by the beensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer by product. '
source, and special nuclear material designated below; to use such material for the purpose (s)and at the plate (s) designated below;to !
j dehver or transfer such material to persons authonied to receive it in accordance with the regulations of the appheable Part(s). This ;*
i license shall be deemed to contain the conditions specified m Section 183 of the Atomic Energy Act of 1954, as amended, and is subject to all applicable rules, regulations and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any ;
conditions specified below. gs
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In accordance with letter dated
,I March 9, 1987, e' ' Veterans Administration Medical Center 3. License number SNM-1605 is amended in Radiation Safety Office (115) its entirety to read as follows: l 42- 50 Irving Street, N.W. '
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Washington, D.C. 20422 I 4 bP r8tica'ddh
- 5. Doclset or August 31, 1991 _' ,
q _ Reference No. 070-02199 : ,
d 6 II) product, source, and/or 7. Chemical and/or physical u 6. Maimum amount that INensee
( special nuclear material form ( may possess at any one tirne j
i onder this beense (lA. Plutonium (principal A. Sealed Source A.1.25 grams (5 individual q RadionuclideFu-238) sources not to exceed $e, ,
4 250milligramseach) l1,
- 9. Authorized use '
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'< A. Implantation in humans as a component of Coratomic Mocel C-101 or C-101-P nuclear-3 powered cardiac pacemakers for clinical evaluation. ? U, p,
al CONDITIONS
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j 10. Licensed material shall be used only at Veterans Administration Medical Center, 50 >
g Irving Street, h.W., Washington, D.C.
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- 11. The specified pcssession limit includes all licensed material possessed by the licensee under this license whether in storage, implanted in patients, or )pf otherwise in use. >
o g 12. The licensee shall report to the U.S. Nuclear Regulatory Comission, Region I, n a.
$,' >I ATTN: Chief, Nuclear Materials Safety and Safeguards Branch, 631 Park Avenue,
@ King of Prussia Pennsylvania 19406, within 74 hours8.564815e-4 days <br />0.0206 hours <br />1.223545e-4 weeks <br />2.8157e-5 months <br /> of occurrence, the death pl tp g of any nuclear pacemaker patient, and any adversst reaction and/or malfunction M involving a pacemaker system, including the leads. A writter, report giving
$ details of the adverse reaction and/or malfunction shall be submitted within 30 days, j
gSg i c .J e LT 13. The licensee shall report to the U.S. Nuclear Paculator/ Comission, Region 1 W ry ATTN: Chief. Nuclear Materials Safety and Sateguards ts anch, 631 Park Avenue, c)a: v) Kino of Prussia, Pennsylvania 19406, within 10 days of lo.s of contact with a nuclearpacemakerpatient.
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The licensee shall continue patient follow-up and replacement procedures for the nuclear pacemaker during the life of the attent. Procedures for recovery g q
1l; and authorized disposal of the nuclear pacema er by return to the manufacturer h p shall be followed upon the death of the patient. , , W bv.rssh Iowm,s,u a ; cmm e Av taur w w w w w maamusumusuntam um w w w w = = + r a sumunuU
rm- _------- _--#--- .-- _------- .--- .-- ----- _.&.7Agrary u.S. NL R CEOUWORY COMWSSION 1 a,grorm ma _ ,, g g g g g I Licen,e number b l . MATERIALS LICENSE SUPPLEMENTARY SHEET g,g,g,_pM05 S l
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] AmendJnenLho. 09 l
) (Continued) CONDITIONS l
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1 15. Sealeo sources or detector cells containing licensed material shall not be >
1 opened or sources removed from detector cells by the licensee. >
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] 16. The licensee may transport licensed material in accordance with the provisions l
) of 10 CFR Part 71, " Packaging and Transportation of Radioactive Material". b i
I 17. Except as specifically provided otherwise in this license, the licensee shall p I conduct its program in accordance with the statements, representations, and i I
procedures contained in the docurpents incidding any enclosures, listed below, b j The Nuclear Regulatory Commission's regulations shall govern unless the state-ments, representations and procedures in the licensee's application and corre- l 3 t
)I spondence are more restrictive than the regulations, p 1 -
N I A. Letter with application dated December 15, 1975 >
I B. Letter dated December 17, 1976 >
l C. Letter dated January 18, 1977 j 0. Letter dated September 12, 1978 [
1 E. Letter dated January 22, 1981 >
2 F. Letter dated July 29, 1982 1 1 G. Letter dated January 23, 1984 k l
H. Letter dated September 12, 1985 )
) I. Section 1 4!tems C. and 1.) and Section !! (Item 1.) of Radiation Safety I
) Guide enclosed with letter dated September 9,1985 l
] J. Letter dated January 29, 1906 p J K. Letter dated March 9, 1987 )
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k For the U.S. Nuclear Regulatory Commission h j orisiral stin 4 pn N 8' 81*'m [
I Date MAR 3 01987 ~
By t l huclear hateriali. :,afety and Safeguards Branch, Region I l j ,
j king of Prussia, Pennsylvania 19406 y I r i k l )
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