MynxGrip Vascular Closure Device (5F, 6F/7F), Mynx Control Vascular Closure Device (5F, 6F/7F), Mynx Control Venous Vasc
FDA premarket approval P040044/S105 · decided 2024-11-15
Approval details
- PMA number
- P040044
- Supplement
- S105
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MynxGrip Vascular Closure Device (5F, 6F/7F), Mynx Control Vascular Closure Device (5F, 6F/7F), Mynx Control Venous Vasc
- Generic name
- Device, hemostasis, vascular
- Applicant
- Cordis US Corporation
- Date received
- 2024-10-18
- Decision date
- 2024-11-15
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- an alternate in-house site in Santa Clara, CA, for bacterial endotoxin testing of the MynxGrip, Mynx Control, and Mynx Control Venous Vascular Closure Devices
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.