MynxGrip, Mynx Ace and Mynx Control Vascular Closure Device (VCD)
FDA premarket approval P040044/S083 · decided 2019-03-14
Approval details
- PMA number
- P040044
- Supplement
- S083
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MynxGrip, Mynx Ace and Mynx Control Vascular Closure Device (VCD)
- Generic name
- Device, hemostasis, vascular
- Applicant
- Cordis US Corporation
- Date received
- 2019-02-12
- Decision date
- 2019-03-14
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- Implement an automated rolling process for the hydrogel component.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.