ML20042A312
| ML20042A312 | |
| Person / Time | |
|---|---|
| Site: | 07001342 |
| Issue date: | 02/09/1982 |
| From: | Purdy D BIOCONTROL TECHNOLOGY, INC. (FORMERLY CORATOMIC |
| To: | Martin T NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I) |
| Shared Package | |
| ML20042A305 | List: |
| References | |
| NUDOCS 8203230317 | |
| Download: ML20042A312 (2) | |
Text
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C = ratomice P.O. BOX 434, INDIANA, PENNSYLVANIA 15701
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PHONE 141213491811 TELEX 86-6658 February 9, 1982 United States Nuclear Regulatory Commission Region 1 631 Park Avenue King of Prussia, PA 19406 Attn:
Mr. Thomas T. Martin, Director Division of Engineering and Technical Inspection subject:
Inspection 70-1342/81-02; Docket No. 70-1342 Gentlemen:
" With regard to your letter of January 25, 1982, the following steps have been taken to prevent any further confusion with regard to the C-101-P pacemaker.
Coratomic has not shipped a C-101-P since June 1, 1981, at which time the C-101-P pacemakers were shipped under the Custom Device Exemptions of the Food and Drug Administration.
Coratomic is preparing a 510(k) submission to the Food and Drug Administration at that agency's request based upon inputs to the Food and Drug Administration from Coratomic. This 510(k) submission will be submitted within the next month and a copy provided to the Nuclear Regulatory Commission.
The Nuclear Regulatory Commission has recently licensed Coratomic for shipment under the Investigational Device Exemption rule of the Food and Drug Administration. Coratomic is now licensed to ship the C-101-P.
We have contacted Allegheny General Hospital and Washington Hospital Center with regard to licensing these institutions, and they are expected to amend their C-101 licenses for the receipt of the C-101-P.
With regard to sarety and efficacy, the C-101-P is equal to or superior to the C-101 since it utilizes more recent and modern circuitry and uses the same nuclear battery.
8203230317 820315 PDR ADOCK 07001342 C
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, If we can be of further help, please do not hesitate to contact US.
Sincerely, CORATOMIC, INC.
(W David L. Purdy President DLP/ns I
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