|
Device | MOSAIC PORCINE BIOPROSTHESIS |
Generic Name | replacement Heart-valve |
Regulation Number | 870.3925 |
Applicant | Medtronic, Inc. 1851 EAST DEERE AVE. SANTA ANA, CA 92705 |
PMA Number | P990064 |
Supplement Number | S019 |
Date Received | 07/02/2007 |
Decision Date | 11/29/2007 |
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 THE ADDITION OF A BORATE BUFFERED SALINE (BBS) SOLUTION PRE-RINSE TO THE P5 AMINO-OLEIC ACID (AOA) PROCESS. |