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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(TM) ARRHYTHMIA CONTROL DEVICE SYSTEMS
ApplicantBOSTON SCIENTIFIC
4100 Hamline Avenue North
St. Paul, MN 55112
PMA NumberP940008
Supplement NumberS003
Date Received02/20/1996
Decision Date08/22/1996
Withdrawal Date 07/20/2012
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Other
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL TO CONSIDER THE INFORMATION PROVIDED IN THIS SUPPLEMENT AS AN ALTERNATIVE RESPONSE TO THE CONDITIONS OF APPROVAL SET FORTH IN THE FDA LETTER DATED NOVEMBER 7, 1995. THE CONDITION REQUIRED THAT REMAINING MINOR SOFTWARE ANOMALIES BE CORRECTED
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