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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.
 
DevicePERIMOUNT PERICARDIAL BIOPROSTHESIS, MODELS 2700, 2800 (PERIMOUNT RSR), 6900P (PERIMOUNT PLUS) AND 3000
Generic Namereplacement Heart-valve
Regulation Number870.3925
ApplicantEDWARDS LIFESCIENCES, LLC.
One Edwards Way
Irvine, CA 92614
PMA NumberP860057
Supplement NumberS022
Date Received06/20/2003
Decision Date01/26/2004
Product Code DYE 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF A POST-FIXATION TISSUE HEAT TREATMENT STEP IN GLUTARALDEHYDE SOLUTION PRIOR TO THE EDWARDS XENOLOGIX TISSUE VALVE PROCESSING STEPS. THE DEVICES, AS MODIFIED, WILL BE MARKETED WITH THE REFERENCE TO THERMAFIX AS THE TRADEMARK/BRAND NAME FOR THE TISSUE PROCESSING METHOD AND WILL BE IDENTIFIED ACCORDING TO THE FOLLOWING MODIFIED MODEL NUMBERS: MODELS 2700TFX, 2800TFX, 6900PTFX, AND 3000TFX.
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