MYNX VASCULAR CLOSURE DEVICE
FDA premarket approval P040044/S002 · decided 2007-09-20
Approval details
- PMA number
- P040044
- Supplement
- S002
- Supplement type
- Special (Immediate Track)
- Trade name
- MYNX VASCULAR CLOSURE DEVICE
- Generic name
- Device, hemostasis, vascular
- Applicant
- Cordis US Corporation
- Date received
- 2007-08-24
- Decision date
- 2007-09-20
- Days to decision
- 27 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- APPROVAL FOR ADDITIONAL WARNINGS REGARDING DEVICE USE AT PARTICULAR PUNCTURE SITE LOCATIONS IN THE INSTRUCTIONS FOR USE (IFU) FOR THE DEVICE.
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