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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.
 
DevicePROTECTA XT CRT-D AND PROTECTA CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATORS WITH CARDIAC RESYNCHRONIZATION; MODEL SW009
Classification Namepulse generator, permanent, implantable
Generic Namepulse generator, permanent, implantable
Applicant
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
8200 coral sea street n.e.
mounds view, MN 55112
PMA NumberP010031
Supplement NumberS171
Date Received10/22/2009
Decision Date03/25/2011
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Review Memo Review Memo
Approval Order Statement 
Approval for protecta xt crt-d d314trg and protecta crt-d d334trg implantable cardioverter defibrillators with cardiac resynchronization, protecta xt dr d314drg, protecta xt vr d314vrg, protecta dr d334drg, and protecta vr d334vrg implantable cardioverter defibrillators, model sw009 application software v1. 0, carelink monitor model 2490c upgrade, cardiosight reader model 2020a upgrade, and model 2491 ddma upgrade.
Approval Order Approval Order
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