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: DIPLOS MODEL 05 A & B
• Generic Name: Implantable pulse generator, pacemaker (non-CRT)
• Applicant: Biotronik, Inc.; 6024 Jean Rd.; Lake Oswego, OR 97035
• PMA Number: P820076
• Supplement Number: S026
• Date Received: 01/22/2018
• Decision Date: 02/21/2018
• Withdrawal Date: 08/05/2019
• Product Code: LWP
• 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  
Use of supplemental sterilization equipment and a new sterilization process for implantable leads and accessories.