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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 NameMEDTRONIC PROTECTA XT CRT-D D314TRM AND PROTECTA CRT-D D334 IMPLANTABLE CARDIOVERTER DEFIBRILLATORS
Classification Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
Generic Namecardiac resynchronization therapy
Applicant MEDTRONIC INC.
PMA NumberP010031
Supplement NumberS178
Date Received12/23/2009
Decision Date11/09/2011
Product Code
NIK[ Registered Establishments with NIK ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Review Memo Review Memo
Approval Order Statement 
Approval for the protecta xt crt-d, d314trm and protecta crt-d d334trm implantable cardiovertcr defibrillators with cardiac rcsynchronization, protecta xt dr d314drm and protecta dr d334drm implantable cardioverter defibrillaiors, model sw009 application software vl. 0, carelink monitor model 2490c upgrade. Cardiosight reader model 2020a upgrade and model 2491 ddma upgrade.
Approval Order Approval Order
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