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 | Pacemaker/ICD/CRT non-implanted components |
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 | S144 |
Date Received | 12/19/2022 |
Decision Date | 06/28/2023 |
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 | Yes |
Approval Order Statement Approval for the Amvia and Solvia family of pulse generators and cardiac resynchronization therapy pacekaer devices, as well as for updated programmer software versions PSW 2204.U and NEO 2204.U, updated Home Monitoring Service Center software version 3.55.0, and updates to the CardioMessenger Smart 4G firmware. |
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