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: Siello S 45/Solia S 45, Siello S 53/Solia S 53, Siello S 60/Solia S 60
• 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: S233
• Date Received: 01/05/2022
• Decision Date: 03/04/2022
• Product Code: DXY
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Labeling Change - PAS
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval for updated labeling for Siello Pacing Leads based on final post approval study results.