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: Acticor Sky HF-T, Rivacor Sky HF-T, Rivacor Rise HF-T, Rivacor Aura HF-T, Acticor Sky HF-T QP, Rivacor Sky HF-T QP, Riva
• Generic Name: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
• Applicant: Biotronik, Inc.; 6024 Jean Rd.; Lake Oswego, OR 97035
• PMA Number: P050023
• Supplement Number: S214
• Date Received: 08/27/2026
• Decision Date: 09/25/2026
• Product Code: MRM
• Advisory Committee: Cardiovascular
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
to update manufacturing processes for high voltage capacitors in ICDs and CRT-Ds