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 | PHYLAX AV ICD SYSTEM |
Generic Name | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) |
Applicant | BIOTRONIK, INC. 6024 Jean Road Lake Oswego, OR 97035 |
PMA Number | P000009 |
Supplement Number | S062 |
Date Received | 03/23/2015 |
Decision Date | 06/19/2015 |
Product Codes |
LWS NIK NKE NVZ |
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 QP CRT-D DEVICE MODELS WITH ONE IS4 PORT, ONE IS-1 PORT AND ONE DF4 PORT ALONG WITH A UPDATED SOFTWARE ¿ PSW 1502.U FOR THE DEVICES. |
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