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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.
 
DeviceCONTAK CD SYSTEM
Generic NameDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
ApplicantBoston Scientific Corp.
4100 HAMLINE AVE NORTH
ST. PAUL, MN 55112
PMA NumberP010012
Supplement NumberS001
Date Received05/07/2002
Decision Date05/20/2002
Product Code NIK 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL OF THE POST-APPROVAL STUDY FOR THE DEVICE.
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