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 | Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (CRT-P) |
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 | S152 |
Date Received | 09/26/2023 |
Decision Date | 10/23/2023 |
Product Code |
NKE |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement new injection mold tooling, a new injection molding machine, and new material to support manufacturing of the sealing plugs used in the BIOTRONIK IPGs and ICDs |
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