ML20248E241
| ML20248E241 | |
| Person / Time | |
|---|---|
| Site: | 07001398 |
| Issue date: | 07/13/1988 |
| From: | Graden K NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III) |
| To: | |
| Shared Package | |
| ML20248E242 | List: |
| References | |
| NUDOCS 8904120174 | |
| Download: ML20248E241 (2) | |
Text
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' ll 'l NRC Form 374 1
p-g PAGE OF PAGES g (5-8 0 U.S. NUCLE AR REGULATORY COMMlMION l
l MATERIALS LICENSE Amendment No. 06 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 q
l deliver or transfer such material to persons authorized to receive it in accordance with the regulations of the applicable Part(s). This N
l license shall be deemed to contain the conditions specified in Section 183 of the Atomic Energy Act of 1954, as amended, and is g
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.
y Licensee N
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In accordance with letter dated i
April 20, 1988 E
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11 William Beaumont Hospital
- 3. License number SNM-1366 is amended in i
Division of Cardiovascular Diseases its entirety to read as follows:
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Reference No.
/" -. ON-01398 i
- 6. llyproduct, source, and/or
- 7. Chemical and/or physical 68, Maximum amount that licensee R
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A. Plutonium (Principle ER) l radionuclides Pu-238)*
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B. Plutonium (Principli M O B. iea'l'eb sou ded ' I.M BE2.5 grams N
s radionuclidePu-238)Q p y4 j g:[ g gJC.pj 'c y (10 individual l
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exceed 250 milligrams "y.,
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- 9. Authorized Use L.,
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To be used for implantation in> humans asta component of Medtronic Model 9000 j
nuclear-powered cardiac pacemakers'for clinical evaluation purposes.
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To be used for implantation in humans as a component of Coratomic Model C-101 nuclear-powered cardiac pacemakers for clinical evaluation purposes.
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CONDITIONS l
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Licensed material shall be used only at the licensee's facilities located at William Beaumont Hospital, 3601 West Thirteen Mile Road, Royal Oak, Michigan.
- 11. The specified possession limit includes all licensed material possessed by the j
l licensee under this license whether in storage, implanted in patients or otherwise i
in use.
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l 8904120174 880713
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REG 3 LIC70 0
SNM-1366 PNU 9N/!
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wsmmmy 70RC Form 374A U.S. NUCLEAR REGULATORY COMMISSION 2
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" l License number l
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SNM-1366 MATERIALS LICENSE l
SUPPLEMENTARY SHEET i
070-01398 p
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Amendment No. 06 l
- 12. The licensee shall not receive or transfer in any single transaction,1 gram or more l
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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 W
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70.54 of 10 CFR Part 70.
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- 13. The licensee shall report to the Materials Licensing Section, U.S. Nuclear l
Regulatory Commission, 799 Roosevelt Road, Glen Ellyn, Illinois 60137 within 24 g
I hours of occurrence, the death of any nuclear pacemaker patient, and any adverse p
i reaction and/or malfunction involving a pacemaker system, including the leads. A i
l written report giving details of the adverse reaction and/or malfunction shall be l
q submitted within 30 days.
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- 14. The licensee shall report to the Materials Licensing'Section, U.S. Nuclear p
Regulatory Commissions 799 Roosevelt Road, Glen Ellyn,* Illinois 60137 within 10 N
days, loss of contactywith a nuclear pacemaker patient. U,
- 15. The licensee shallUcontinun patient follow-up andfeplacem'ent, procedures for the
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q nuclear pacemaker;during the 1ife of the patientp and'the procedures for recovery g
and authorized disposal of the.n0 clear: pacemaker? by' return to3he manufacturer shall s
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be followed upon' the death'ofsthe) patient.d !/"
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I Except as specifically prov' deYo/therw1se"innthis, license, the licensee shall N
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q conduct its program intaccordance withsthezstatements,. representations, and procedures containbd inM he doc'ument's The Nuclear Regulatory Commission!-s!'r'h including "any' enclosures, listed below t
I e dlations shalligovern?unless the statements, i
representations and' procedures,inCthet icenseefs application and correspondence are 6
more restrictive th'an theiregulati6ns".li '
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Letters dated May,2, 1973, June;5; M976 and'Apri L 20', 1988.
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4 Original Signed d
Date: July 13, 1988 By Kathy J. Graden bm- - -- -m E=~)f l
Materials Licensing Section, Region III
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