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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 | S001 |
Date Received | 04/06/2006 |
Decision Date | 05/16/2007 |
Product Code |
MGB |
Docket Number | 07M-0285 |
Notice Date | 07/20/2007 |
Advisory Committee |
Cardiovascular |
Supplement Type | Panel Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE MYNX VASCULAR CLOSURE SYSTEM. THE DEVICE IS INDICTED FOR USE TO SEAL FEMORAL ARTERIAL ACCESS SITES WHILE REDUCING TIMES TO HEMOSTASIS AND AMBULATION IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL ENDOVASCULAR PROCEDURES UTILIZING A 5F, 6F, OR 7F PROCEDURAL SHEATH. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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