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. |
|
Device | BIOTRONIK GEMNOS 04, 04A, AND TC 04 |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | BIOTRONIK, INC. 6024 Jean Road Lake Oswego, OR 97035 |
PMA Number | P820076 |
Supplement Number | S020 |
Date Received | 05/04/1995 |
Decision Date | 12/22/1995 |
Withdrawal Date
|
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 CHANGE IN THE BURN-IN PROCESSING OF THE WILSON GREATBATCH BATTERIES WHICH ARE USED IN YOUR LISTED PACEMAKERS. THIS PROCESS CHANGE IS A REDUCTION OF THE BATTERY BURN-IN TIME FROM 35 DAYS TO 4 DAYS |
|
|