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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 NameFORTIFY AND FORTIFY ASSURA ICDS
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nametranstelephonic follow-up/monitoring system
ApplicantST. JUDE MEDICAL, IMPLANTABLE ELECTRONIC SYSTEMS DIVISION
PMA NumberP910023
Supplement NumberS338
Date Received05/30/2014
Decision Date06/18/2014
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 
Add a visual inspection step for the manufacture process of the devices.
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