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™ S-ICD Model A209; EMBLEM™ MRI S-ICD Model A219
• Generic Name: Implantable cardioverter defibrillator (non-CRT)
• Applicant: BOSTON SCIENTIFIC CORPORATION; 4100 HAMLINE AVENUE NORTH; ST. PAUL, MN 55112-5798
• PMA Number: P110042
• Supplement Number: S081
• Date Received: 03/27/2017
• Decision Date: 04/13/2017
• 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

Approval Order Statement  
Additional manufacturing inspection step and associated specification and inspection criteria to distinguish case half discontinuities from dents.