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 | GEMINI(R) THETA MODEL 415A CARDIAC PACER |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | TELECTRONICS PACING SYSTEMS, INC. 7400 SOUTH TUCSON WAY ENGLEWOOD, CO 80112 |
PMA Number | P830007 |
Supplement Number | S023 |
Date Received | 01/15/1988 |
Decision Date | 04/06/1988 |
Product Code |
LWP |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
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