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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceEDWARDS PRIMA PLUS STENTLESS PORCINE BIOPROSTHESIS
Classification Namereplacement heart-valve
Generic Namereplacement heart-valve
Regulation Number870.3925
Applicant
EDWARDS LIFESCIENCES, LLC.
one edwards way
irvine, CA 92614
PMA NumberP000007
Supplement NumberS038
Date Received12/14/2012
Decision Date06/11/2013
Product Code
DYE[ Registered Establishments with DYE ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR THE USE OF THE RE-DESIGNED AND RE-PROGRAMMED SENSITECH TAGALERT TEMPERATURE ALARM INDICATION WITH NEW ELECTROMAGNETIC INFERENCE/ELECTROMAGNETIC DISCHARGE (EMI/ESE) PROTECTION IN THE DEVICES.
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