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: INGEVITY+ and INGEVITY MRI Pace/Sense leads
• Generic Name: Implantable pulse generator, pacemaker (non-CRT)
• Applicant: Boston Scientific; 4100 Hamline Ave. N; St Paul, MN 55112
• PMA Number: P150012
• Supplement Number: S145
• Date Received: 05/09/2023
• Decision Date: 05/17/2023
• Product Codes: LWP NVN
• Advisory Committee: Cardiovascular
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: Yes
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Introduction of a digital microscope to verify removal of medical adhesive during the Drug Collar Bonding manufacturing process.