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: D010 INOGEN™ MINI ICD VR, D011 INOGEN™ MINI ICD VR, D012 INOGEN™ MINI ICD DR, D013 INOGEN™ MINI ICD DR, D020 DYNAGEN™ MI
• Applicant: Boston Scientific; 4100 Hamline Ave. N; St Paul, MN 55112
• PMA Number: P960040
• Supplement Number: S510
• Date Received: 09/26/2025
• Decision Date: 10/22/2025
• 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  
to add an alternative Macro Laser Weld System to perform the laser weld process on high voltage ICD and CRT-D devices