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: Model 2889 EMBLEM S-ICD Automated Screening Tool, v1.01
• Generic Name: Implantable cardioverter defibrillator (non-CRT)
• Applicant: Boston Scientific Corporation; 4100 Hamline Ave. N; St Paul, MN 55112
• PMA Number: P110042
• Supplement Number: S067
• Date Received: 10/19/2016
• Decision Date: 07/06/2017
• Product Code: LWS
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval for the Automated Screening Tool software to aide in determining whether the S-ICD System is appropriate.