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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 NamePERIMOUNT PERICARDIAL BIOPROSTHESIS, MODELS 2700, 2800 (PERIMOUNT RSR), 6900P (PERIMOUNT PLUS) AND 3000
Classification Namereplacement heart-valve
Generic Namebioprosthetic heart valve
Regulation Number870.3925
ApplicantEDWARDS LIFESCIENCES, LLC.
PMA NumberP860057
Supplement NumberS022
Date Received07/01/2003
Decision Date01/26/2004
Product Code
DYE[ Registered Establishments with DYE ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - specifications
Expedited Review Granted? No
Combination Product No
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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