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 | MYNX ACE VASCULAR CLOSURE DEVICE (MYNX ACE) |
Generic Name | Device, hemostasis, vascular |
Applicant | Cordis US Corporation 14201 NW 60th Avenue Miami Lakes, FL 33014 |
PMA Number | P040044 |
Supplement Number | S062 |
Date Received | 12/19/2014 |
Decision Date | 03/03/2015 |
Product Code |
MGB |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR MINOR MODIFICATIONS TO THE MYNX ACE DEVICE THAT INVOLVE BUTTON 3, THE PACKAGING TRAY, AND INSTRUCTIONS FOR USE (IFU) ASSOCIATED WITH BUTTON 3. |
|
|