MYNX VASCULAR CLOSURE DEVICE WITH GRIP TECHNOLOGY
FDA premarket approval P040044/S034 · decided 2011-10-04
Approval details
- PMA number
- P040044
- Supplement
- S034
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MYNX VASCULAR CLOSURE DEVICE WITH GRIP TECHNOLOGY
- Generic name
- Device, hemostasis, vascular
- Applicant
- Cordis US Corporation
- Date received
- 2010-09-30
- Decision date
- 2011-10-04
- Days to decision
- 369 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- APPROVAL FOR A MODIFIED VERSION OF THE MYNX VASCULAR CLOSURE DEVICE CALLED THE MYNX VASCULAR CLOSURE DEVICE WITH GRIP TECHNOLOGY.
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