MynxGrip and Mynx Ace Vascular Closure Device
FDA premarket approval P040044/S078 · decided 2018-11-16
Approval details
- PMA number
- P040044
- Supplement
- S078
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MynxGrip and Mynx Ace Vascular Closure Device
- Generic name
- Device, hemostasis, vascular
- Applicant
- Cordis US Corporation
- Date received
- 2017-11-20
- Decision date
- 2018-11-16
- Days to decision
- 361 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- Approval to add a new vendor for the hydrogel sealant components and to extend the shelf life of the hydrogel component to 25 months.
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