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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 & CONFIENT
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Namecardiac resynchronization therapy defibrillator (crt-d) system
ApplicantBOSTON SCIENTIFIC
PMA NumberP960040
Supplement NumberS190
Date Received02/18/2009
Decision Date03/18/2009
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason labeling change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to the setscrew design, seal plug design, labeling for the torque wrench, and the model 6628 torque wrench accessory kit as a stand alone accessory.
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