Mynx Control and Mynx Grip Vascular Closure Device
FDA premarket approval P040044/S088 · decided 2021-11-05
Approval details
- PMA number
- P040044
- Supplement
- S088
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Mynx Control and Mynx Grip Vascular Closure Device
- Generic name
- Device, hemostasis, vascular
- Applicant
- Cordis US Corporation
- Date received
- 2021-10-08
- Decision date
- 2021-11-05
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- Use of an additional supplier for the syringe component used in the MynxGrip and Mynx Control Vascular Closure Devices.
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