ML20198B396
| ML20198B396 | |
| Person / Time | |
|---|---|
| Site: | 07001209 |
| Issue date: | 11/01/1998 |
| From: | Paulson L MEDTRONIC, INC. |
| To: | Grobe J NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III) |
| Shared Package | |
| ML20198B400 | List: |
| References | |
| NUDOCS 9812180157 | |
| Download: ML20198B396 (1) | |
Text
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MITOHN '
Medtronic, Inc.
l 7000 Central Avenue N.E.
Minneapolis, MN 55432-3.576 i
Telephone:(612) 514-4000 November 1,1998 2,
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Safety and Safeguards Branch L9, N
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U.S. Nuclear Regulatory Commission
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801 Warrenville Road W
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Lisle, IL 60532-4351 9$. w W
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 1,1998.
This report is submitted as an update of the Summary of Clinical Evaluation Study submitted to
' the United States Nuclear Regulatory Commission on November 1,1997.
If you have any questions regarding this report, please contact me at 1-800-328-2518 (x6232).
Sincerely, Medtronic, Inc.
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Lany Pa on, P.E.
Post Market Surveillance Manager Clinical Operations l
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