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 | S003 |
Date Received | 01/19/1996 |
Decision Date | 07/19/1996 |
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 ALTERNATE VENDOR FOR THE CALIBRATED MODULE ASSEMBLY FOR THE MICRO-PACE MODEL 4553, PART NUMBER 02-025-000 |
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