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 | VARIOUS MODELS OF PHILOS/AXIOS/PROTOS/CYLOS PG'S |
Generic Name | Pulse generator, permanent, implantable |
Applicant | BIOTRONIK, INC. 6024 Jean Road Lake Oswego, OR 97035 |
PMA Number | P950037 |
Supplement Number | S049 |
Date Received | 01/11/2007 |
Decision Date | 03/26/2007 |
Product Code |
NVZ |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR: 1) UPDATES TO THE INTEGRATED CIRCUIT USED FOR ELECTROGRAM SENSING AND NON-RATE RESPONSIVE PACEMAKER TIMING, 2) MODIFICATIONS TO THE ELECTRONIC MODULE, AND 3) IMPLEMENTATION OF MULTI-LINGUAL LABELING. |
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