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 | Defibrillator, Implantable, Dual Chamber, Automatic Implantable Cardioverter with Cardiac Resynchronization |
Generic Name | DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER |
Applicant | BIOTRONIK, INC. 6024 Jean Road Lake Oswego, OR 97035 |
PMA Number | P050023 |
Supplement Number | S107 |
Date Received | 02/16/2017 |
Decision Date | 05/06/2017 |
Product Code |
MRM |
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 PSW 1702.U programmer software including support for Multi-Pole Pacing (MPP.) |
Post-Approval Study | Show Report Schedule and Study Progress |
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