|
Device | MYNX VASCULAR CLOSURE DEVICE |
Generic Name | Device, hemostasis, vascular |
Applicant | Cordis US Corporation 14201 NW 60th Avenue Miami Lakes, FL 33014 |
PMA Number | P040044 |
Supplement Number | S005 |
Date Received | 03/11/2008 |
Decision Date | 05/16/2008 |
Product Code |
MGB |
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 |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE FOLLOWING CHANGES TO THE MANUFACTURING PROCESSES: 1) REPLACING THE HEATED DIE NECKER MACHINE WITH A HOT AIR NECKER MACHINE; AND 2) REPLACING THE GLASS MOLD BALOON BLOWER MACHINE WITH A METAL MOLD BALLOON BLOWER MACHINE. |