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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 NamePROTECTA CRT-D, PROTECTA DF4 CRT-D, PROTECTA XT CRT-D, PROTECTA XT DF4 CRT-D
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Namecardiac resynchronization therapy
Applicant MEDTRONIC INC.
PMA NumberP010031
Supplement NumberS314
Date Received06/11/2012
Decision Date09/10/2012
Product Code
LWS[ Registered Establishments with LWS ]
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 
Protecta crt-d model d334trg; protecta df4 crt-d model 334trm: protecta xtcrt-d model d314trg; and protecta xt df4 crt-d model d314trm.
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