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: RESONATE™ HF, RESONATE™ EL, MOMENTUM™ EL, VIGILIANT™ EL, PERCIVA™ HF, PERCIVA™
• Generic Name: Implantable cardioverter defibrillator (non-CRT)
• Applicant: Boston Scientific; 4100 Hamline Ave. N; St Paul, MN 55112
• PMA Number: P960040
• Supplement Number: S476
• Date Received: 03/23/2022
• Decision Date: 08/26/2022
• Product Code: LWS
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Postapproval Study Protocol
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval of the MANAGE-HF Post Approval Study (PAS) to be transitioned to the HeartLogic PAS Analysis Plan.