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 AND 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 | S036 |
Date Received | 12/18/2012 |
Decision Date | 03/18/2013 |
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 |
Review Memo | Review Memo |
Approval Order Statement APPROVAL FOR THE ILESTO 7/5 VR-T ICD, ILESTO 7/5 VR-T DX ICD, ILESTO 7/5 DR-T ICD, ILESTO 7/5 HFT CRT-D; IFORIA 7/5 VR-T ICD, IFORIA 7/5 VR-T DX ICD, IFORIA 7/5 DR-T ICD, IFORIA 7/5 HF-T CRT-D; AND THE PSW 1205.U. |
Approval Order | Approval Order |
Post-Approval Study | Show Report Schedule and Study Progress |
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