Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | MICRO-PACE MODEL 4553 DUAL CHAMBER DDD TEMPORARY CARDIAC PACEMAKER |
Generic Name | Generator, pulse, pacemaker, external programmable (for electrophysiological studies only) |
Regulation Number | 870.1750 |
Applicant | PACE MEDICAL 391 TOTTEN POND RD. WALTHAM, MA 02451 |
PMA Number | P920032 |
Supplement Number | S002 |
Date Received | 11/27/1995 |
Decision Date | 04/26/1996 |
Product Code |
JOQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE PACESETTER, INC., MODEL 3070B PRIVATE LABEL VERSION OF THE PACE MEDICAL MODEL 4575 |
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