|
Device | PSW 2100.U and NEO 2100.U |
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 | S122 |
Date Received | 03/16/2021 |
Decision Date | 04/30/2021 |
Product Code |
NKE |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for updates to programmer software to versions PSW 2100.U and NEO 2100.U to reduce the number of capacitor reformations and move the timepoint for capacitor reformations from overnight to daytime for various Biotronik implantable cardiac devices. |