ML20134K828

From kanterella
Jump to navigation Jump to search
Forwards Medtronic Implantable Demand Isotopic Pulse Generator Laurens-Alcatel Model 9000 Summary of Clinical Evaluation Study, Dtd Oct 1996
ML20134K828
Person / Time
Site: 07001209
Issue date: 11/01/1996
From: Paulson L
MEDTRONIC, INC.
To: Grobe J
NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III)
Shared Package
ML20134K830 List:
References
NUDOCS 9611200051
Download: ML20134K828 (1)


Text

-.

~ --.

~

MklDEIlC, Medtronic, Inc.

7000 Central Avenue,N.E.

{

Minneapolis, MN 55432-3576 i

Telephone: (612)574-4000

)

i r'( D @ @

SV

\\

'!t November 1, 1996 h

V l

/

Chief of Nuclear Materials y

Safety and Safeguards Branch U.S. Nuclear Regulatory Commission Region III 801 Warrenville Road Lisle, IL 60532-4351 Attn: John A. Grobe, Chief

Dear Mr. Grobe:

Enclosed is a summary of'the clinical evaluation study of the Medtronic Implantable Demand ISOTOPIC PULSE GENERATOR, Laurens-Alcatel Model 9000 The closing date for the data in this report is October 1, 1996.

This report is submitted as an update of the Summary of Clinical Evaluation Study submitted to the United States Nuclear Regulatory i

Commission on November 1, 1995.

If you have any questions regarding this report, please contact me at 1-800-328-2518 (X6232).

Sincerely, MEDTRONIC, INC.

Larry Pa on, P.E.

Post Market Surveillance Manager l

I-Clinical Operations icb_

cc: Patricia C. Vacca - NRC te%p 200021 N II E 9611200051 961101 PDR ADOCK 07001209

.