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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.
 
DeviceSUBCURANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantBoston Scientific Corporation
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP110042
Supplement NumberS039
Date Received06/16/2014
Decision Date06/27/2014
Product Code LWS 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR ADDING LANGUAGE IN THE IMPLANT MANUALS OF THE REFERENCED DEVICES WHICH STATES AND CLARIFIES THAT GOOD TISSUE CONTACT WITH THE ELECTRODE AND PULSE GENERATOR IS IMPORTANT FOR OPTIMIZING SENSING AND THERAPY DELIVERY.
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