MYNX ACE VASCULAR CLOSURE DEVICE
FDA premarket approval P040044/S060 · decided 2015-01-09
Approval details
- PMA number
- P040044
- Supplement
- S060
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MYNX ACE VASCULAR CLOSURE DEVICE
- Generic name
- Device, hemostasis, vascular
- Applicant
- Cordis US Corporation
- Date received
- 2014-12-12
- Decision date
- 2015-01-09
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- IMPLEMENT A REWORK STEP TO RELOAD THE HYDROGEL IN THE MYNX ACE DEVICE (MODEL MX6740).
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