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: Edora 8 HF-T QP 407137 Edora 8 HF-T 407138 Evity 8 HF-T QP 407139 Evity 8 HF-T 407140 Enitra 8 HF-T QP 407141 Enitra 8 H
• Generic Name: Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
• Applicant: Biotronik, Inc.; 6024 Jean Rd.; Lake Oswego, OR 97035
• PMA Number: P070008
• Supplement Number: S172
• Date Received: 09/25/2025
• Decision Date: 09/25/2026
• 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
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
the next generation of the Home Monitoring Service Center (HMSC)