MYNX VASCULAR CLOSURE DEVICE
FDA premarket approval P040044/S001 · decided 2007-05-16
Approval details
- PMA number
- P040044
- Supplement
- S001
- Supplement type
- Panel Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MYNX VASCULAR CLOSURE DEVICE
- Generic name
- Device, hemostasis, vascular
- Applicant
- Cordis US Corporation
- Date received
- 2006-04-06
- Decision date
- 2007-05-16
- Days to decision
- 405 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- 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.
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