ML20212E126

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Confirms That Min of Three Conventional Demand Bipolar Pacemakers Will Be Inserted for Each Medtronic Isotopic Pacemaker,Thus Permitting Greater Confidence in Results. Results Will Be Reported Using Forms Supplied by Medtronic
ML20212E126
Person / Time
Site: 07001369
Issue date: 05/03/1973
From: Piccone V
VETERANS ADMIN. MEDICAL CENTER, BROOKLYN, NY
To: Mason T
US ATOMIC ENERGY COMMISSION (AEC)
Shared Package
ML20212D767 List:
References
3088, NUDOCS 8608120616
Download: ML20212E126 (1)


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VETERANS ADMINISTRATION REGULATORY FILE CY HosevAL BROOKLYN NEw YORK 11209 May 3, 1973 00< ftEPLY

"" " 112 DeclJ 70-/169 Mr. James R. Mason Materials Branch Directorate of Licensing United States Atomic Energy Commission Washington, D.C.

205

Dear Mr. Mo9on:

This letter will confirm our recent conversation regarding a series of control pacemakers in the clinical study of the Medtronic Isotopic pacemaker with endocardial leads.

A series of control pacemakers, using conventional Medtronic demand bi-polar pacemakers, will be carried out along with the insertion of the allowed number of isotopic pacemakers. We will insert a minimum of three conventional demand bi-polar pacemakers for each isotopic pacemaker, the larger number of conventional pacemakers being relative simply to the opportunity at hand. The larger number should permit greater confidence in the results.

The results on the series of control pacemakers will be r rported using the Central Data Recording Ibrms already supplied by the Medtronic Corporation.

Sincerely yours, y k.

VINCENT A. PICCONE, JR., M.D.

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