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: NG3 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR(ICD). ORIGEN , INOGEN, DYNAGEN EL ICD'S. NG2.5 IMPLANTABLE CARDIOVERTER DEFIB
• Generic Name: Implantable cardioverter defibrillator (non-CRT)
• Applicant: Boston Scientific; 4100 Hamline Ave. N; St Paul, MN 55112
• PMA Number: P960040
• Supplement Number: S372
• Date Received: 05/04/2016
• Decision Date: 05/25/2016
• 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  
Addition of a new acrylic dispense system in the pulse generator header manufacturing process.