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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.
 
Device• ACUITY X4 Connector Tool Model 4625 • AICD Lead Stylets Firm Model 6971 • AICD Lead Stylets Soft Model 6972 • Suture S
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantBoston Scientific
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP910073
Supplement NumberS188
Date Received02/04/2026
Decision Date04/10/2026
Product Code LWS 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for minor labeling changes, removal of paper IFU, and minor dimensional changes to sterile pouches
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