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: EMBLEM AND EMBLEM MRI S-ICD SYSTEM
• Generic Name: Implantable cardioverter defibrillator (non-CRT)
• Applicant: Boston Scientific Corporation; 4100 Hamline Ave. N; St Paul, MN 55112
• PMA Number: P110042
• Supplement Number: S064
• Date Received: 09/12/2016
• Decision Date: 10/12/2016
• 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 an alternate sterilization cycle for pulse generators.