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. |
|
Device | PERIMOUNT PERICARDIAL BIOPROSTHESIS, MODELS 2700, 2800 (PERIMOUNT RSR), 6900P (PERIMOUNT PLUS) AND 3000 |
Generic Name | replacement Heart-valve |
Regulation Number | 870.3925 |
Applicant | EDWARDS LIFESCIENCES, LLC. One Edwards Way Irvine, CA 92614 |
PMA Number | P860057 |
Supplement Number | S022 |
Date Received | 06/20/2003 |
Decision Date | 01/26/2004 |
Product Code |
DYE |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
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. |
|
|