ML20204B844
| ML20204B844 | |
| Person / Time | |
|---|---|
| Site: | 07002077 |
| Issue date: | 06/10/1986 |
| From: | Glenn J NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I) |
| To: | |
| Shared Package | |
| ML20204B848 | List: |
| References | |
| NUDOCS 8607300509 | |
| Download: ML20204B844 (2) | |
Text
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Amamamg(OF g PACES fiS. NUCLE A"'. REGU LATORY COMMISSION q' V U g-g MATERIALS LICENSE Amendment No. 02 Pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93-438), and Title 10, i g Code of Federal Regulations, Chapter 1. Parts 30,31,32,33,34,35,40 and 70, and in reliance on statements and representations 4 heretofore made by the beensee a heense is hereby issued authorizing the licensee to receise, acquire, possess, and transfer byproduct, 4' source, and special nuclear material designated below, to use such material for the purpose (s) and at the place (s) designated below; to
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( deliver or transfer such material to persons authorized to receive it in accordance with the regulations of the applicable Part(s). This le i heense shall be deemed 'o contain the conditions specified in Section 183 of the Atomic Energy Act of 1954, as amended, and is k f subject to all appheable rules, regulations and orders of the Nuclear Regulatory Commission now or hereafter in effect a onditions specified below. si fP Licensee I:I
-[! In accordance with application dated i1 y1. October 21, 1985, !j Suburban General Hospital 3. ucense number SNM-1581 is amended in 1l t its entirety to read as follows: []
1' 2. 2701 DeKalb Pike 'ti gl Il 4 Norristown, Pennsylvania 19404 4. Expiration date June 30, 1991 I!
4 I g 5. Docket or h 4 Reference No. 070-02077 7; A; 6. Byproduct, source, and/or 7. Chemical and/or physical 8. Maximum amount that licensee t!
{ special nuclear material form - may possess at any one time ll under this license si A. Plutonium (Principal A. Sealed sources A. 10 grams (40 individual I!
l radionuclide Pu-238) sources not to exceed ( l gl i 250. milligrams each) tl 4
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k9. Authorized use ti 4! Il
%A . Implantation in humans as a component of Coratomic Model C-101 nuclear-powered 4 f cardiac pacemakers for clinical evaluation.
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- tl y, CONDITIONS tl
$. (I Mj10. Licensed material shall be used only at Suburban General Hospital, 2701 DeKalb t
[ Pike, Norristown, Pennsylvania.
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The specified possession limit includes all licensed material possessed by the licensee under this license whether in storage, implanted in patients, or oth-erwise in use.
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$ i 1 12. The licensee shall report to the U.S. Nuclear Regulatory Commission, Region I, ll l!
g ATTN: Chief, Nuclear Materials Safety and Safeguards Branch, 631 Park Avenue, King of Prussia, Pennsylvania 19406, within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of occurrence, the death [
y gl of any nuclear pacemaker patient, and any adverse reaction and/or malfunction p 3 involving a pacemaker system, including the leads. A written report giving y 3 details of the adverse reaction and/or malfunction shall be submitted within Ej 4 30 days. El 4 ll f13. The licensee shall report to the U.S. Nuclear Regulatory Commission, Region I, f ATTN: Chief, Nuclear Materials Safety and Safeguards Branch, 631 Park Avenue, 'g f
y gl King of Prussia, Pennsylvania 19406, within 10 days of loss of contact with a f g M nuclear pacemaker patient. El 3
% 14. The licensee shall continue patient follow-up and replacement procedures for kc El l'
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the nuclear pacemaker during the life of the patient. Procedures for recovery and authorized disposal of the nuclear pacemaker by return to the manufacturer ly :
g l chall be followed upon the death of the patient. y ws; g y N 860610 g ,gggy m ,gyy y 3y,,yy,m my_J SNM-1581 PDR
Forsh 374A U.S. NUCL E REGULATcRY COMMISSION Z GE OF PAGES Lic nse number g MATERIALS LICENSE g,C ,, , ,, g , f,,, ,,, ,,,,,, k j SUPPLEMENTARY SHEET 070-02077 >
b Amendment No. 02 l h
(Continued) CONDITIONS E :
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- 15. Sealed sources containing licensed material shall not be opened. E
- 16. The licensee may transport licensed material in accordance with the provisions I y
of 10 CFR Part 71, " Packaging and Transportation of Radioactive Material". p i
- 17. Except as specifically provided otherwise in this license, the licensee shall N conduct its program in accordance with the statements, representations, and I procedures contained in the documents including any enclosures, listed below. l The Nuclear Regulatory Commission's regulations shall govern unless the state- y ments, representations and procedures in the licensee's application and corre- p spondence are more restrictive than the regulations. I h
A. Application dated August 7, 1975 B. Letter dated September 18, 1975 l g
C. Letter dated October 24, 1975 g D. Letter dated October 27, 1980 g E. Letter dated October 21, 1985 N h
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For the U.S. Nuclear Regulatory Commission Original Signed By:
John E. Glocm Date JUN 101986 By y Nuclear Materials Safety and y
- Safeguards Branch, Region I E
- King of Prussia, Pennsylvania 19406 g l
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