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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, PROGENY CRT-D AND NG CRT-D MODELS
Classification Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
Generic Namecardiac resynchronization therapy-defibrillator
ApplicantBOSTON SCIENTIFIC CORPORATION
PMA NumberP010012
Supplement NumberS355
Date Received05/09/2014
Decision Date07/16/2014
Product Code
NIK[ Registered Establishments with NIK ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for model 2868 application software version 3. 04 and firmware version a_v1. 04 with patch v4. 01 and firmware version b_v1. 02 with patch v3. 01 for the devices.
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