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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 DF4 PROTECTA XT/PROTECTA/SECURA/MAXIMO II VR/DR ICDS
Classification Nameimplantable cardioverter defibrillator (non-crt)
Applicant MEDTRONIC INC.
PMA NumberP980016
Supplement NumberS358
Date Received05/31/2012
Decision Date06/25/2012
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 
Update to the vendor inspection of a flex component, a change to the die attach cure process and removal of parallel gap welding line testing.
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