ML20127H092

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Application for Amend to License SNM-1345,authorizing Possession & Use of 1.75 G Pu-238 as Component of Coratomic Model C-101 nuclear-powered Cardiac Pacemaker for Clinical Evaluation Purposes
ML20127H092
Person / Time
Site: 07001366
Issue date: 05/03/1985
From: Augustine R
HEALTH & HUMAN SERVICES, DEPT. OF
To:
NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I)
Shared Package
ML20127H046 List:
References
03799, 3799, NUDOCS 8506260204
Download: ML20127H092 (2)


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DEPARTMENT OF HEALTH O HUMAN SERVICES.

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National Institutes of Health Bethesda, Maryland 20205 BuiWing : 21 Romn

110 (301)49& 2254 May 3, 1985 U. S. Nuclear Regulatory Commission, Region I Nuclear Material Section B 631 Park Avenue King of Prussia, PA 19406

Dear Sir or Ms.:

This' letter'is to request that the National Institutes of Health's special nuclear materials license SNM-1345 be amended to reflect the following changes.

1.

On March 1, 1985, NIH explanted a 28'Pu powered cardiac pacemaker from a patient due to lead failure. The NRC was notified according to our license conditions and a 30 day report dated March 21, 1985 was also filed. The name of the company, address, SNM license number and pacemaker information are included below.

A.

Coratomic 28'Pu Nuclear Powered Pacer Model C-101 serial number 259.

B.

Transferred from SNM 1345 to: Coratomic, Inc.

300 Indian Springs Road Indiana, PA 15701 SNM #1319 C.

Shipped from NIH 4/4/85 and received by Coratomic on 4/5/85.

, 2.

Possession limits for SNM-1345 item 8A should be amended to read 1.75 grams (7 individual sources not to exceed 250 milligrams each).

3 On October 25, 1984, NIH explanted a 88'Pu powered pacemaker from a patient due to lead failure. The NRC was subsequently notified

'according to our license conditions. A 30 day written report, dated November 15, 1984, was filed.- The name of the company, address, SNM license number and pacemaker information are included below.

A.

Arco ***Pu powered pacer model NU-5, serial number 138, B.

Transferred from SNM-1345 to: Arco Nuclear The Sartomer Company Bolmar & Nields Street Westchester, PA 19380 SNM #37-14916-01 "0mCl/1 RECORD COPY" 8506260204 850611 l!14 r U.3793 REG 1 LIC70 Ll1

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SNM-1345 PDR MAY 131985

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-Page 2 C.

Shipped from NIH'on' 3/4/85 and received by the Sartomer Company on 3/5/85.

4.

Possession limits.for'SNM-1345 items 68, 7B and 8L may be entirely.

deleted.

.j If-you have any questions please. contact me at 496-2254.

Sincerely, R. J. Augustine, Ph.D.

Radiation Safety Officer,.NIH; cc: Director Procurement' Division Department of Energy Richland Operations Office P. O. Box 550 Richland, Washington 99352

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United States Nuclear Regulatory Commission Division of Engineering and Technical' Programs Region I 631 Park Avenue King of Prussia, Pennsylvania 19406 l

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