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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceSubcutaneous Implantable Cardioverter Defibrillator
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantBOSTON SCIENTIFIC CORPORATION
4100 HAMLINE AVENUE NORTH
ST. PAUL, MN 55112-5798
PMA NumberP110042
Supplement NumberS145
Date Received08/25/2020
Decision Date09/10/2020
Product Codes LWS NVY 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Add a 30-minute dwell time step after all sterilization loads for S-ICD pulse generators.
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