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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.
 
DeviceCOGNIS CRT-D
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantBoston Scientific Corp.
4100 HAMLINE AVE NORTH
ST. PAUL, MN 55112
PMA NumberP010012
Supplement NumberS189
Date Received07/22/2008
Decision Date11/17/2008
Product Code LWP 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE NEXT GENERATION (G2) RF COMMUNICATOR, MODEL 6476, WHICH IN CONJUNCTION WITH THE LATITUDE SYSTEM SOFTWARE, V5.0, MODEL 6488, WILL ADD LATITUDE SUPPORT FOR COGNIS TELIGEN PGS.
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