ML20211K376
| ML20211K376 | |
| Person / Time | |
|---|---|
| Site: | 07003044 |
| Issue date: | 10/21/1986 |
| From: | Mccann G NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III) |
| To: | |
| Shared Package | |
| ML20211K381 | List: |
| References | |
| NUDOCS 8702260593 | |
| Download: ML20211K376 (2) | |
Text
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pummmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmmm-------mm 7 g NRC Form 374 1 2 g PAGE OF PAGES g 15 84) U.S. NUCLEAR REGULATORY COMMISSION U
MATERIALS LICENSE I l y Pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93-438), and Title 10, g Code of Federal Regulations, Chapter I, Parts 30,31,32,33,34,35,40 and 70, and in reliance on statements and representations y g heretofore made by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byproduct, y source, and special nuclear material designated below; to use such material for the purpose (s) and at 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). This i N
license shall be deemed to contain the conditions specified in Section 183 of the Atomic Energy Act of 1954, as amended, and is N subject to all applicable rules, regulations and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any g conditions specified below. g Licensee N li l
- 1. The Cleveland Clinic Foundation 3. License number SNM-1971 M
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- 2. 9500 Euclid Avenue g13
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- . ., f ll;El Cleveland, OH 44106 g Qe' , 4. hip (iration,date October 31, 1990 y
y . %) 'ps 5. Docket or g sT Reference No. ^l b.t 070-03044 N p
$ 6. Byproduct, source, and/or .yo 7. Chemical and/or physical QMaximum amount that licensee N special nuclear material ,
form .m %may possess at any one time U U) X'y ,,
" u~nder this license N A. Plutonium (Principab/ A SealedSource,s['I A. 10 grams (40 lg radionuclide Pu-238)- [ti,. \ +p) ([R b individual sources l
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d" s f i \ J not to exceed 250 l
?r 3 ' } a! VMA/)'s va,<.
Gt (Q s,
milligrams each)
(4 t B. Plutonium (Principal) W. B.) Sealed ~Soupces' f: % B. 15 grams (60 g j radionuclide Pu-238)
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' $~ individual sources not to exceed 250 N
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C[ milligrams each) ly C. Plutonium (Principal Y ,s C.gSe'aled Sou[cesVi/ %{_'y C. 1.35 grams (6 y radionuclide Pu-238) '//f/) 'im~ individual sources y N
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<d' O ' not to exceed 225 milligrams each)
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il g 9. Authorized Use ' <*
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(= A. Implantation in humans as a component of Coratomic Model C-101 nuclear powered cardiac l N pacemaker for clinical evaluation purposes, j N
l B. Implantation in humans as a component of Coratomic Model C-101P nuclear powered cardiac g pacemaker for clinical evaluation purposes. g N T 4 C. Implantation in humans as a component of Cordis Nuclear Omni-stanicor Model 184A g N nuclear-powered cardiac pacemakers for clinical evaluation purposes. E, N El N
CONDITIONS N
N g 10. Licensed material shall be used only at the licensee's facilities located at y 9500 Euclid Avenue, Cleveland, Ohio.
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260593 5 l OCT 21 1986 SN"~MP COPY h h\)
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R Form 374A U.S. NUCLEAR REIULATf.RY COMMISSION , 7 7 Lici.nse number l MATERIALS LICENSE 9NM 1971 Dodeur Referem nmnkt SUPPLEMENTARY SHEET n70 0'4044 l N
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- 11. The specified possession limit includes all licensed material possessed by the l licensee under this license whether in storage, implanted in patients, or otherwise n in use.
12 The licensee shall report to the U.S. Nuclear Regulatory Commission, Region III, ATTN: Chief Nuclear Materials Safety and Safeguard Branch, 799 Roosevelt Road, l y
Glen Ellyn, Illinois 60137, within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of cccurrence, the death of any nuclear y pacemaker patient, and any adverse reaction and/or malfunction involving a pacemaker i system, including the leads. A written report giving details of the adverse reaction I and/or malfunction shall be submitted within 30 days.
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- 13. The licensee shall report,to,the U.S. Nuclear Regulatory Commission, Region III, ATTN: Chief, Nuclear Materi' al Safety and Safeguard' Branch, 799 Roosevelt Road, Glen Ellyn, Illinois 60137, within 10 days of loss of ~ contact with a nuclear i
pacemaker patient. L I i
- 14. The licensee shall continue patient follow-up and replacemenbprocedures for the l nuclear pacemaker during the life of the patient. Procedures'for recovery and y authorized disposal of the nuclear pacemaker by return to the -manufacturer '
shall be y followed upon theTdeath of the-patient.. ; i i i
- 15. The licensee shall follow the manufacturer.'s protocol dated March 2, 1983, for the Coratomic, Inic. Model C-101-P~ Nuclear-Power Pacemak'ers.
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- 16. Except as specifically'provided'dth'erwise;ini this license, the licensee shall l conduct its program in accordance'~with the! statements,' representations, and procedures contained in the!documentsiincluding any enclosures', listed below.
The Nuclear Regulatory Commission's regulations.shall govern'unless the statements, representations and; procedures in the. licensee's. application and correspondence are l more restrictive than the regulations.
A. Letters dated February 9,.1976, April 19, 1976, July 9, 1976, May 14, 1981, b August 10, 1984 and July. 9,1986.
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For the U.S. Nuclear Regulatory Commission R I >
Original Signed Date October 21, 1986 By George M. McCann F Materials Licensing Section, Region III R P
COPY I
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