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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
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Namecardiac resynchronization therapy defibrillator (crt-d) system
ApplicantBOSTON SCIENTIFIC-CRM
PMA NumberP960040
Supplement NumberS218
Date Received03/10/2010
Decision Date09/07/2010
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to the cleaning process and moving a weld process from a supplier to boston scientific corporation.
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