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: Drug Eluting Permanent Right Ventricular/Right Atrial Pacemaker Electrodes
• Generic Name: implantable pacemaker Pulse-generator
• Regulation Number: 870.3610
• Applicant: Biotronik, Inc.; 6024 Jean Rd.; Lake Oswego, OR 97035
• PMA Number: P950037
• Supplement Number: S235
• Date Received: 02/17/2022
• Decision Date: 03/15/2022
• Product Code: DXY
• 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  
Tensile test optimization and lead tip welding inspection changes.