ML20205C057
| ML20205C057 | |
| Person / Time | |
|---|---|
| Site: | 07003028 |
| Issue date: | 09/06/1985 |
| From: | Friedman L NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I) |
| To: | |
| Shared Package | |
| ML20205C061 | List: |
| References | |
| NUDOCS 8509200067 | |
| Download: ML20205C057 (2) | |
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U.S. NUCLEAR REGULATORY COMMISSION PAoE PAGES te 82)
MATERIALS LICENSE Pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93-438), and Title 10, p
Code of Federal Regulations, Chapter I, Parts 30,31,32,33,34,35,40 and 70, and in reliance on statements and representations i
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 at the place (s) designated below; to deliver or transfer such material to persons authorized to receive it in accordance with the regulations of the applicabic Part(s);and to E
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 Nud a gegulatory Commission now or hereafter in effect and to any conditions specified below.
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Ucensee I-Lawrence General Hospital
- 3. License number SNM-1960
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1 General Street Lawrence, Massachusetts 01842
- 4. Ex'piration date August 31, 1990 070-03028
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- 5. Docket or
- SNM-1578 Reference No.
- 6. Byproduct, source,and/or
- 7. Chemical and/or physical
- 8. Maximum amount that licensee special nuclear material form
.3 may possess at any one time under this license A. Plutonium (Principle A. Sealed source
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A. On source not to exceed radionuclide 500 milligrams Plutonium 238)
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- 9. Authorized use
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As a component of the ARC 0 Nuclear Model NU-5 nuclear powered cardiac pacemaker for l
clinical evaluation purposes.
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- 10. Licensed material shall be used only at the. licensee's facilities, 1 General Street, Lawrence, Massachusetts.
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- 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.
- 12. The licensee shall not receive or transfer in any single transaction 1 gram or more of plutonium-238 contained in nuclear-powered pacemakers without notifying the Division of Safeguards, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555, c
and, in addition, completing and distributing Form NRC-741 as required by Section 70.54 of 10 CFR Part 70.
- 13. The licensee shall report to the Materials Branch, U.S. Nuclear Regulatory Commission, Region I, Nuclear Materials Cection, 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 of any nuclear pacemaker patient, and any adverse reaction and/or malfunction involving a pacemaker system, including the leads. A written report giving details of the adverse reaction and/or malfunction I
shall be submitted within 30 days.
- 14. The licensee shall report to the Materials Branch, U.S. Nuclear Regulatory Commission, Region I, Nuclear Materials Section, 631 Park Avenue, King of Prussia, Pennsylvania 19406, within 10 days, loss of contact with a nuclear pacemaker patient.
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NRC Form 374A U.S.
EAR REGULATORY COMMISSION PAGE 9
OF 9
PAGES License nurnber
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"'*"*g"'1960 Sf MATERIALS LICENSE h
SUPPLEMENTARY SHEET 070-03028 El P!
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CONDITIONS
- 15. The licensee shall continue patient follow-up and replacement procedures for the
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nuclear pacemaker during the life of the patient; and procedures for recovery and E
t authorized disposal of the nuclear pacemaker by return to the manufacturer shall be Eh 4
followed upon the death of the patient.
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Except as specifically provided otherwise by this license, the licensee shall possess and use licensed material described in Items 6, 7, and 8 of this license in accordance R
with statements, representations, and procedures contained in application which was h
transmitted by letter from R. Ashton Smithi P.re'sldent, Rudolph Muto, M.D., Alan I.
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Burbank, M.D., William A. Cook,'M.D.','and Mahmodd'Kowsari, M.D., dated h
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October 15, 1975 and letter 'froin James W. Beattie, M.D.',' dated June 27, 1985.
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Nuclear Regulatory Commissio6's regulations shall govern the, licensee's statements 93 l
in applications or letters', unless the statements are more; restrictive than the Ej
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l For the U.S. Nuclear Regulatory Commission p-t Original Signed By:
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Nuclear Materials Safety and
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