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™ EL ICD: D150, D151, D152, D153; INOGEN™ EL ICD: D140, D141, D142, D143; ORIGEN™ EL ICD: D050, D051, D052, D053
• Generic Name: Implantable cardioverter defibrillator (non-CRT)
• Applicant: Boston Scientific; 4100 Hamline Ave. N; St Paul, MN 55112
• PMA Number: P960040
• Supplement Number: S378
• Date Received: 07/07/2016
• Decision Date: 08/01/2016
• 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  
Alternate supplier of the titanium raw material used for capacitor can manufacturing.