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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 NameMAXIMO II DF-4 CRT-D, MAXIMO II DF-4 ICD, MAXIMO II ICD, PROTECTA DF4-ICD, PROTECTA ICD, PROTECTA XT DF-4 ICD, PROTECTA
Classification Nameimplantable cardioverter defibrillator (non-crt)
Applicant MEDTRONIC INC.
PMA NumberP980016
Supplement NumberS379
Date Received08/23/2012
Decision Date09/20/2012
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 acceptance criteria inspection process for all die locations on all hybrids.
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