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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 FAMILY
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Namecardiac resynchronization therapy defibrillator (crt-d) system
ApplicantBOSTON SCIENTIFIC
PMA NumberP960040
Supplement NumberS193
Date Received04/20/2009
Decision Date05/26/2009
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the programmer sw model 2868 v1. 05 for the teligen and cognis families of devices.
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