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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 XT VR DF4, PROTECTA VR DF4, SECURA VR DF4, & MAXIMO II VR DF4 ICD'S
Classification Nameimplantable cardioverter defibrillator (non-crt)
Applicant MEDTRONIC INC.
PMA NumberP980016
Supplement NumberS353
Date Received05/14/2012
Decision Date06/13/2012
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Align header manufacturing processes of the protecta xt vr (d314vrm), protecta vr (d334vrm), secura vr (d204vrm) and maxmio ii vr (d264vrm) df4 icds with currently manufactured devices.
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