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 | EVIA/ENTOVIS DR/DR-T/SR-T & VARIOUS OTHER MODELS OF PULSE GENERATORS |
Generic Name | Pulse generator, permanent, implantable |
Applicant | BIOTRONIK, INC. 6024 Jean Road Lake Oswego, OR 97035 |
PMA Number | P950037 |
Supplement Number | S083 |
Date Received | 06/08/2010 |
Decision Date | 11/26/2010 |
Product Code |
NVZ |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Review Memo | Review Memo |
Approval Order Statement CHANGE IN THE USB CABLE ASSEMBLY, AS WELL AS THE SUPPLIER FOR THE CABLE, TO BE USED WITH THE ESTEEM PROGRAMMER. |
Approval Order | Approval Order |
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