MynxGrip Vascular Closure Device and two components of Mynx Control Vascular Closure Device (VCD)
FDA premarket approval P040044/S093 · decided 2022-10-27
Approval details
- PMA number
- P040044
- Supplement
- S093
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MynxGrip Vascular Closure Device and two components of Mynx Control Vascular Closure Device (VCD)
- Generic name
- Device, hemostasis, vascular
- Applicant
- Cordis US Corporation
- Date received
- 2022-09-29
- Decision date
- 2022-10-27
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- Source components from a supplier's new facility.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.