MYNXGRIP VASCULAR CLOSURE DEVICE (6F/7F)
FDA premarket approval P040044/S040 · decided 2012-01-13
Approval details
- PMA number
- P040044
- Supplement
- S040
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MYNXGRIP VASCULAR CLOSURE DEVICE (6F/7F)
- Generic name
- Device, hemostasis, vascular
- Applicant
- Cordis US Corporation
- Date received
- 2011-11-14
- Decision date
- 2012-01-13
- Days to decision
- 60 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- APPROVAL FOR INTEGRATING THE CATHETER DELIVERY SYSTEM OF THE MYNXCADENCE DEVICE WITH THE HYDROGEL SEALANT OF THE MYNX WITH GRIP TECHNOLOGY DEVICE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MYNXGRIP VASCULAR CLOSURE DEVICE AND ISINDICATED 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 6F OR 7F PROCEDURAL SHEATH.
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