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 | MODEL 4553 DUAL CHAM. DDD TEMP.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 | S001 |
Date Received | 12/06/1994 |
Decision Date | 08/28/1995 |
Product Code |
JOQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE MICRO-PACE MODELS 4570, 4573, & 4575 DUAL CHAMBER DDD TEMPORARY CARDIAC PACEMAKERS |
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