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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.
 
DeviceACC SUP CONNECTOR QUAD PSA TO IS4; ACC SUP SUTURE SLEEVE; ACC SUP KIT LD CAP; STRL PKG LEAD REPAIR KIT; ACC STY STR .016
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantBoston Scientific
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP910073
Supplement NumberS183
Date Received09/05/2025
Decision Date09/16/2025
Product Code LWS 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
for removing an Ethelyne Oxide (EO) chemical indicator dot applied to the outside of sterile packaging pre-sterilization and evaluated visually post-sterilization
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