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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.
 
DeviceRES-Q FAMILY OF ICD/ICD LEADS, RES-Q MICRON FAMILY OF ICDS
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantBOSTON SCIENTIFIC
4100 Hamline Avenue North
St. Paul, MN 55112
PMA NumberP940008
Supplement NumberS030
Date Received10/02/2012
Decision Date11/09/2012
Withdrawal Date 07/20/2012
Product Code LWS 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
SOFTWARE UPGRADE TO THE EXISTING STERILIZER SYSTEM, A CHANGE IN THE EXISTING STERILIZATION PROCESS AND ADDITION OF A NEW STERILIZATION CHAMBER.
Post-Approval StudyShow Report Schedule and Study Progress
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