MynxGrip Vascular Closure Device, Mynx Control Vascular Closure Device (VCD)
FDA premarket approval P040044/S092 · decided 2022-06-27
Approval details
- PMA number
- P040044
- Supplement
- S092
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MynxGrip Vascular Closure Device, Mynx Control Vascular Closure Device (VCD)
- Generic name
- Device, hemostasis, vascular
- Applicant
- Cordis US Corporation
- Date received
- 2022-06-02
- Decision date
- 2022-06-27
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- Supplier facility relocation for the manufacture of one component of MynxGrip Vascular Closure Device and one component of Mynx Control Vascular Closure Device.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.