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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 RENEWAL CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantBoston Scientific Corp.
4100 HAMLINE AVE NORTH
ST. PAUL, MN 55112
PMA NumberP010012
Supplement NumberS121
Date Received03/27/2006
Decision Date08/09/2006
Product Code LWP 
Advisory Committee Cardiovascular
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
CHANGE TO INCLUDE CIRCUIT BOARD PREPARATION TO THE CLONMEL, IRELAND FACILITY.
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