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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 DEFIBRILLATOR (S-ICD) SYSTEM
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantBOSTON SCIENTIFIC CORPORATION
4100 HAMLINE AVENUE NORTH
ST. PAUL, MN 55112-5798
PMA NumberP110042
Supplement NumberS009
Date Received06/10/2013
Decision Date08/28/2013
Product Code LWS 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Review MemoReview Memo
Approval Order Statement  
APPROVAL FOR MODEL 3200 Q-TECH PROGRAMMER TO BE USED WITH SQ-RX® PULSE GENERATOR (MODEL 1010) OF THE SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD®) SYSTEM ONLY.
Approval OrderApproval Order
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