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 | STRATOS LV/LV-T, EVIA HF/HF-T, ENTOVIS HF/HF-T CRT-P'S |
Generic Name | Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P) |
Applicant | BIOTRONIK, INC. 6024 Jean Road Lake Oswego, OR 97035 |
PMA Number | P070008 |
Supplement Number | S057 |
Date Received | 09/25/2014 |
Decision Date | 03/19/2015 |
Product Code |
NKE |
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 REMOVAL OF THE SCAN LOCATION RESTRICTIONS FOR THE PROMRIPACEMAKER SYSTEM AS WELL AS UPDATES TO THE ICS 3000/ RENAMIC PROGRAMMER SOFTWARE (1403.U) FOR THE DEVICES. |
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