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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 4-SITE MODELS
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantBoston Scientific Corp.
4100 HAMLINE AVE NORTH
ST. PAUL, MN 55112
PMA NumberP010012
Supplement NumberS212
Date Received05/11/2009
Decision Date11/10/2010
Product Code LWP 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Review MemoReview Memo
Approval Order Statement  
APPROVAL FOR: 1) THE ELEVATED PRESSURE LABELING MODIFICATIONS FOR TELIGEN ICD MODELS E103, E111, E102 AND E110; AND 2) THE NEW 4-SITE HEADER FOR TELIGEN ICD MODELS E103 AND E111.
Approval OrderApproval Order
Post-Approval StudyShow Report Schedule and Study Progress
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