|
Device | CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESES |
Generic Name | replacement Heart-valve |
Regulation Number | 870.3925 |
Applicant | EDWARDS LIFESCIENCES, LLC. One Edwards Way Irvine, CA 92614 |
PMA Number | P860057 |
Supplement Number | S118 |
Date Received | 01/29/2014 |
Decision Date | 08/04/2014 |
Product Code |
DYE |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A CHANGE IN THE SANITATION FREQUENCY OF THE PROCESS WATER SYSTEM USED AT ONE OF THE MANUFACTURING FACILITIES. |