ML20129B719
| ML20129B719 | |
| Person / Time | |
|---|---|
| Site: | 07001717 |
| Issue date: | 06/24/1985 |
| From: | Kinneman J NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I) |
| To: | |
| Shared Package | |
| ML20129B724 | List: |
| References | |
| NUDOCS 8507290244 | |
| Download: ML20129B719 (2) | |
Text
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"*m&mmLwn ,czaza m ats i m %i m s ces2z- m m te-82) U.S. NUCLEAR REGULATORY COMMISSION PAGE OF PAGES MATERIALS LICENSE Amendment No. 05 h N
Pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93-438), and Title 10, j Code of Federal Regulations, Chapter I, Parts 30,31,32,33,34,35,40 and 70, and in reliance on statements and representations heretofore made by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byproduct, source, and special nuclear material designated below; to use such material for the purpose (s) and ?.t the place (s) designated below; to e deliver or transfer such material to persons authorized to receive it in accordance with the regulations of the applicable Part(s);and to import such byproduct and source material. This license shall be deemed to contain the conditions specified in 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.
Licensee
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i In accordance with letter dated i
$ November 30, 1984 -
l l Norwalk Hospital 3. Ucense number SNM-1504 is amended in its entirety to read as follows:
- 2. Norwalk, Connecticut 06856 p
- 4. Expiration date June 30, 1990
$feren e No.070-01717
- 6. Byproduct, source, and/or 7. Chemical and/or physical 8. Maximum amount that licensee N special nuclear material form may possess at any one time under this license A. 6.25 grams (25 individual
? A. Plutonium (Principal' A. Sealed Source (s) k radionuclide Pu-238) sources not to exceed 250 i milligrams each) $ B. Plutonium (Principal B. Sealed Source (s) B. 6.25 grams (25 individual # radionuclide Pu-238) .
sources not to exceed 250 milligrams each) C. Plutonium (Principal C. Sealed Source (s) C. 2.1 grams (10 individual radionuclide Pu-238) sources not to exceed 210
. milligrams each)
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- 9. Authorized use A. Implantation in humans as a component of Coratomic Model C-101 nuclear-powered g cardiac pacemakers for clinical evaluation purposes, o A
B. Implantation in humans in accordance with " Human Implantation Protocal for the Coratomic C-101-P Radioisotope Powered Cardiac Pacer," dated March 2, 1983. C. Implantation in humans as a component of Medtronic Model 900 nuclear-powered cardiac pacemakers for clinical evaluation purposes. CONDITIONS
- 10. Licensed material shall be used only at the licensee's facilities, at Norwalk, Connecticut 06856.
- 11. 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. ,
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- 12. The licensee shall not receive or transfer in any single transaction one (1) gram or more of plutonium 238 contained in nuclear-powered pacemakers without notifying the g Division of Safeguards, U. S. Nuclear Regulatory Commission, Washington, D. C. 20555, E
and, in addition, completing and distributing Form NRC-741 as required by Section j , N 70.54 of 10 CFR 70. 8507290244 850624 }U' 9 I l k&m.ns%%amm me v e'= N-1Nf PDR Emmmhw3N J
K """""- 55 = = = = Z rf T 1-4 MATERIALS LICENSE SNM-1504 1 g 4 SUPPLEMENTARY SHEET pk 070-0171'7 p )# Amendment No. 05 v$ (continued) CONDITIONS 4
- 13. The licensee shall report to the U. S. Nuclear Regulatory Commission, Region I, $
p Nuclear Materials Section, 631 Park Avenue, King of Prussia, Pennsylvania 19406, p within twenty-four (24) hours of occurrence, the death of any nuclear pacemaker 4 patient, and any adverse reaction and/or malfunction involving a pacemaker system, ' l including the leads. A written report giving details of the adverse reaction and/or malfunction shall be submitted within thirty (30) days. 4 14. The licensee shall report to the U. S. Nuclear Regulatory Commission, Region I, h Nuclear Materials Section, 631 Park Avenui, King of Prussia, Pennsylvania 19406, pl withinten(10) days,losso{cgtactwith'a[ nucle,arypacemakerpatient. r %d
- 15. The licensee shall continue vpatient follow-up and replace. ment procedures for the nuclear pacemaker durinbthe life of the patient. Procedures for recovery and 1 authorized disposal of"sthe nuclear pacemaker by return to'the, manufacturer shall be followed upon the- death of the patient. /? 'ir ,
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- 16. Except as specifically Y' i? provided)otherwise by this1 cense, d~
)1 U the Jicensee shall possess g and use licensed m'aterial described in> Items 6,7, hnd 8 of this license in accordance '
with statements, representatiois~,7and probedures1, contained in letters dated [q! q t November j 30,1984fa~nd shall govern May the )icensee's 29p19,851,ts in applicatioils or, letters, unless theThe Nu statemen i statements are morgrestrictive'th'anJthe. e uhtfoM. %
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i I i I ii For the U.S. Nuclear Regulatory Commission Original Sicnod By: - JUN 2 41985 yam, ginnman I Date gy Nuclear Materials Safety and > Safeguards Branch, Region I E King of Prussia, Pennsylvania 19406 > i NJ22223k&TEATEK"-LTAVATEhvJiME2W.6TME25mv5}}