ML20214V441
| ML20214V441 | |
| Person / Time | |
|---|---|
| Site: | 07001209 |
| Issue date: | 03/24/1975 |
| From: | Griffin B MEDTRONIC, INC. |
| To: | Mason J NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III) |
| Shared Package | |
| ML20197E336 | List:
|
| References | |
| 0634, 634, NUDOCS 8610020293 | |
| Download: ML20214V441 (1) | |
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'Cj,4 f/c.... m, Inc.
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3055 O!d Hi hway Eight G
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q March 24, 1975 O
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Nuclear Regulators Commission Materials Branch
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James R. Mason Washington, D.C.
20545 Gentlemin:
The purpose of this letter is to request an amendment to license number SNM 1156 to allow continuation of our clinical investigation of the Alcatel Model 9000 Isotopic Pulse Generator beyond May 23, 1975.
Specifically, Medtronic requests an extension of the investigational period of one year beginning May 24, 1975 and ending May 24, 1976.
T.iad tronic agrees to continue adherance to condition 12 amendment 11 of SUM 1156.
Medtronic does however request a change in the Clinical Investigational Plan dated March 21, 1973.
The request is to allow discontinuance of the regnirement for implanting physicians to g a ther non-nuclear implan t control data.
The Kleitman criteria for evaluation of the random failure rate of the Model 9000 are l
independent of the control data.
The "Medtronic Product Perform-ance Report" MC 74551, Mcdtronic, Inc. (September 1974) provides the necessary non-nuclear random failure standards for comparison in the clinical investigation of the Model 9000.
Your prompt reply to this requent would be greatly appreciated.
vnry tenly yours, Medtronic, Inc.
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