Premarket Approval (PMA)

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.

• Device: Sentus ProMRI OTW QP S, Sentus ProMRI OTW QP S-xx/49, Sentus ProMRI OTW QP L, Sentus ProMRI OTW QP Lxx/49m, Evia HF, Evi
• 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: S132
• Date Received: 09/30/2021
• Decision Date: 10/29/2021
• 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  
Optimize the sterilization process parameters for P01 and P02 and propose a load change for P01.