ML19242B658

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Requests Extension of Certificate of Compliance 6291 for Pacemaker Model 400
ML19242B658
Person / Time
Site: 07106291
Issue date: 06/25/1979
From: Worzewski W
BIOTRONIK SALES, INC.
To: Macdonald C
NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
References
NUDOCS 7908090256
Download: ML19242B658 (1)


Text

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June 25,1979

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Charles E. MacDonald USNRC ~

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Ref: FCTR: EB N.

71-6291

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Dear Mr. MacDonald:

Referring to your letter of June 6,1979 regarding the Certifi-care of Compliance No. 6291 for the Model No. 400, which expires August 31, 1979, we hereby apply for an extension of the Certificate of Compliance No. 6291 for Model No.

400, until August 31, 1981.

This extension is necessary because the majority of pacemakers distributed in accordance with the above certificate are still implanted and will, upon explanterion, be returned to us in accordance with the terms of the license under which these pacemakers were implanted by the licensed institutions and physicians.

Sincerely yours, BIOTRONIK SALES INC.

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