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: Dynagen, Inogen, Origen Implantable Cardiac Defibrillators (ICDs)
• Generic Name: Implantable cardioverter defibrillator (non-CRT)
• Applicant: Boston Scientific; 4100 Hamline Ave. N; St Paul, MN 55112
• PMA Number: P960040
• Supplement Number: S368
• Date Received: 03/23/2016
• Decision Date: 04/14/2016
• Product Code: LWS
• 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  
Update work instructions for the manufacturing inspection process to define acceptable criteria for a cosmetic defect in high voltage capacitors.