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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 NamePRIZM HE/3/VITALITY/2/AVT/CONFIENT/TELIGEN
Classification Nameimplantable pulse generator, pacemaker (non-crt)
ApplicantBOSTON SCIENTIFIC-CRM
PMA NumberP960040
Supplement NumberS240
Date Received12/20/2010
Decision Date01/19/2011
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Automation of inspections for the pulse generators.
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