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 Electrode
• Generic Name: Implantable cardioverter defibrillator (non-CRT)
• Applicant: Boston Scientific Corporation; 4100 Hamline Ave. N; St Paul, MN 55112
• PMA Number: P110042
• Supplement Number: S128
• Date Received: 09/18/2019
• Decision Date: 10/10/2019
• Product Codes: LWS NVY
• 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  
Updates to inspection criteria for defects on the terminal boot of the EMBLEM S-ICD electrode.