|
Device | CARPENTIER-EDWARDS VALVED CONDUIT, MODEL 4300 |
Generic Name | replacement Heart-valve |
Regulation Number | 870.3925 |
Applicant | EDWARDS LIFESCIENCES, LLC. One Edwards Way Irvine, CA 92614 |
PMA Number | P870056 |
Supplement Number | S047 |
Date Received | 03/05/2012 |
Decision Date | 04/04/2012 |
Withdrawal Date
|
01/28/2022 |
Product Code |
DYE |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR ADDING TEXT TO THE WARNINGS AND COMPLICATIONS SECTIONS OF THE EDWARDS MODEL 4300 VALVED CONDUIT IFU IN ORDER TO STRENGTHEN THESE STATEMENTS. |