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 PMS 1000 PROGRAMMING AND MONITORING SYSTEM WITH SOFTWARE MODULE SWM 1000, VERSION C01.C02.U |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | BIOTRONIK, INC. 6024 Jean Road Lake Oswego, OR 97035 |
PMA Number | P820076 |
Supplement Number | S019 |
Date Received | 05/02/1995 |
Decision Date | 01/24/1996 |
Withdrawal Date
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08/05/2019 |
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 |
Approval Order Statement APPROVAL FOR THE MODEL PMS 1000 PROGRAMMING AND MONITORING SYSTEM WITH SOFTWARE MODULE SWM 1000, VERSION C01.C02.U |
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