ML20237F899

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Application for Amend to License SNM-1305,authorizing Participation in Research Study Involving Implantation of Coratomic C-100 Series Nuclear Powered Pacemakers Containing Pu-238
ML20237F899
Person / Time
Site: 07001331
Issue date: 09/04/1975
From: Bhyana J, Chardack W, Gage A
VETERANS ADMIN. MEDICAL CENTER, BUFFALO, NY
To: Mason J
NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
Shared Package
ML20236P571 List:
References
1824, NUDOCS 8708130220
Download: ML20237F899 (1)


Text

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VETERANS ADMINISTRATION

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HOSPITAL 3495 BAILEY AVENUE BUFFALO, NEW YORK 14215 Septerber 4 1975 m nE,cy

JR> h R MAIL SPECIAL DEIVERY M

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Chief, Materials Branch hi([/

Division of Materials and S(EP[,,@s Fuel Cycle Facility Licensing U. S. Nuclear Regulatory Commission.-]

1975

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Attention:

Mr. J. R. Mason

$1EK Gentlemen:

Tl to Re: Application for license amendment to participate in a research study 1

involving the implantation of Coratomic C-100 Series Nuclear Powered Pacemakers, each containing 250 milligrams of Pu-238 ( 4.3 curies).

The Buffalo Veterans Administration Hospital hereby requests an amendment to its Special Nuclear Materials License No.1305 to implant a maximum of 12 Coratomic C-100 Series Pacemakers annually during the study.

The Buffalo Veterans Administration Hospital agrees to follow the Protocol on file at the Division of Materials and Fuel Cycle Facility Licensing entitled, " Human Clinical Protocol for the Coratomic C-100 Series of Radio-isotope Powered Cardiac Pacers", dated July 1,1975. Copies of this Protocol have beenprovided to the above institution and are on file at that institution.

Drs. Andrew A. Gage, Milliam M. Chardack and J. N. Bhayana vill be participating in this atucy. Please amend Special Nuclear Materials License No.1305 presently in effect to include Drs. Chardack and Bhayana, members of this curgical staff.

All correspondence relative to the patients or to the license may be sent to me.

Sincerely yours, b M) h Andrew A. Cage, M. D.

Chief, Surgical Service ghiefofStaff Physicians responsible for the stud :

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