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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 NameCOGNIS, INCEPTA, ENERGEN AND PUNCTUA CRT-D DEVICES
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Namepulse generator
ApplicantBOSTON SCIENTIFIC CRV
PMA NumberP010012
Supplement NumberS300
Date Received08/28/2012
Decision Date11/30/2012
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Review Memo Review Memo
Approval Order Statement 
Approval for software, firmware, and hardware enhancements and modifications to the incepta, energen, punctua, cognis, and teligen devices.
Approval Order Approval Order
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