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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 NameDYNAGEN & DYNAGEN X4 CRT-D'S; INOGEN & INOGEN X4 CRT-D'S; ORIGEN & ORIGEN X4 CRT-D'S; COGNIS CRT-D
Classification Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
Generic Namecardiac resynchronization therapy-defibrillator
ApplicantBOSTON SCIENTIFIC CORP.
PMA NumberP010012
Supplement NumberS341
Date Received09/30/2013
Decision Date04/11/2014
Product Code
NIK[ Registered Establishments with NIK ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - specifications
Expedited Review Granted? No
Combination Product No
Review Memo Review Memo
Approval Order Statement 
Approval for the following changes: 1) new pulse generator models listed above and modifications to the model 2868 programmer application software used to communicate with the new devices and existing devices; and 2) model 3140 zoom wireless transmitter and associated modifications to the model 3120 prm software.
Approval Order Approval Order
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