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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 PULSE GENERATORS
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Namecardiac resynchronization therapy defibrillator (crt-d) system
ApplicantBOSTON SCIENTIFIC-CRM
PMA NumberP960040
Supplement NumberS224
Date Received08/16/2010
Decision Date10/15/2010
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of second source diode suppliers (st micro and minco technology labs) for the hcvm and som used in the cognis and teligen pulse generators.
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