ML20212H379

Amend 2 to License SNM-1694 for Mercer Medical Ctr,Amending License in Entirety

ML20212H379
Person / Time
Site:	07002430 (SNM-1694-A-02, SNM-1694-A-2)
Issue date:	07/31/1986
From:	Glenn J NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I)
To:
Shared Package
ML20212H383	List: ML20212H379 ML20212H394 ML20212H404 ML20212H422
References
NUDOCS 8608140053
Download: ML20212H379 (2)

Text

v 33m'-3---mmmmm-mm-g' NRC Form 374 l ll w

NE I

OF 7

N ES g! (5-84)

U.S. NUCLEAR REGULATCRY COMMISSION I

M El MATERIALS LICENSE Amendment No. 02 gl 4

f Pursuant to t,he Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93-f 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

i 4 heretofore made by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byprcduct, yl 4j source, and special nuclen material designated below; to use such material for the purpose (s) and at the pine (s) designated below; to ll

% deliver or transfer such material to persons authorized to receive it in accordance with the regulations of the applicable Part(s). This 5i license shall be deemed to contain the conditions specified in Section 183 of the Atomic Energy Act of 1954, as amended, and is f subject to all applicable rules, regulations and orders of the Nuclear Regulatory Commission now or hereafter in effe i

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pp g conditions specified below.

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I Licensee h

In accordance with application dated

3. $nsbub'b I

Mercer Medical Center SNM-1694 is amended in its entirety to read as follows:

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s Box 1658

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4 U' P ration date

)i X i July 31, 1991 446 Bellevue Avenue q.

Trenton, New Jersey 08607

5. Docket or i

s Reference No.

070-02430

{ 6. Byproduct, source, and/or

7. Chemical and/or physical V 8. Maximum amount that licensee special nuclear material form

- $may possess at any one time

, under this license l

g A. Sealed Source

./

A.4.5 grams (individual l

f A. Plutoniurn (principal l

y radionuclide Pu-238) sources not to exceed 4

i I 225 milligrams each)

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Authorized use e

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Implantation in humans as a component of Cordis Nuclear Omni-Stanicor Model 184A

4 nuclear-powered cardiac pacemakers for clinical evaluation.,

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5 CONDITIONS, k

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Licensed material shall be.used only at Mercer MedicalsCenter, 446 Bellevue Avenue, Trenton, New Jersey.

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'tl( 11. The specified possession limit includes-all-licensed material possessed by the 1

licensee under this license whether in storage, implanted in patients, or l

jl otherwise in use.

f12. The licensee shall report to the U.S. Nuclear Regulatory Commission, Region I, j

ATTN: Chief, Nuclear Materials Safety and Safeguards Branch, 631 Park Avenue, f

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 1

of any nuclear pacemaker patient, and any adverse reaction and/ e malfunction K

involving a pacemaker system, including the leads. A written report giving 3

details of the adverse reaction and/or malfunction shall be submitted within l!

30 days.

Ai 13. The licensee shall report to the U.S. Nuclear Regulatory Commission, Region I, 2,

ATTN: Chief, Nuclear Materials Safety and Safeguards Branch, 631 Park Avenue, M

King of Prussia, Pennsylvania 19406, within 10 days of loss of contact with a j

nuclear pacemaker patient.

f'14. Sealed sources or detector cells containing licensed material shall not be g

opened or sources removed from detector cells by the licensee.

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U.S. NU_R REGULATORY COMMISSION 2

2

• PAGE 07 PAGE1 N

i R,C Ferm 374A i

License number i

SNM-1694 l

MATERIALS LICENSE l

SUPPLEMENTAnY SHEET 070-02430 i

1 l

Amendment No. 02 l

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(Continued)

CONDITIONS I

i

15. The licensee may transport licensed material in accordance with the provisions g

I of 10 CFR Fart 71, " Packaging and Transportation of Radioactive Material".

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16. The licensee shall continue patient follow-up and replacement procedures for i

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the nuclear pacemaker during the life of the patient.

Procedures for recovery l

and authorized disposal of the nuclear pacemaker by return to the manufacturer l

shall be followed upon the death of the patient.

I 17.

Except as specifically provided otherwisi 6 this license, the licensee shall l

1 conduct its program in accordance with the' statements, representations, and i

~

I I

procedures contained in the documents ir.cluding any enclosures, listed below.

l 1he Nuclear Regulatory Commission's regulations shall govern unless the state-l ments, representations and procedures in the licensee's application and corre-y g

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spondence are more restrictive than the regulations.

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A.

Application transmitted with letter dated October 27, 1976 It hl I

B.

Letter dated August 27, 1981

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C.

Letter dated May 9, 1986 l

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F-l For the U.S. Nuclear Regulatory Comission Origirm1 Signed DYI

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Date JUL 311986 By 1

huclear Materials Safety and gi t]l I

i Safeguards Branch, Region I I

King of Prussia, Pennsylvania 19406 j

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