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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameTELIGEN 4-SITE MODELS
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Namecardiac resynchronization therapy defibrillator (crt-d) system
ApplicantBOSTON SCIENTIFIC
PMA NumberP960040
Supplement NumberS198
Date Received05/11/2009
Decision Date11/10/2010
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Review Memo Review 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 Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
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