MYNX VASCULAR CLOSURE DEVICE
FDA premarket approval P040044/S021 · decided 2009-12-11
Approval details
- PMA number
- P040044
- Supplement
- S021
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MYNX VASCULAR CLOSURE DEVICE
- Generic name
- Device, hemostasis, vascular
- Applicant
- Cordis US Corporation
- Date received
- 2009-10-23
- Decision date
- 2009-12-11
- Days to decision
- 49 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- APPROVAL FOR CHANGES TO THE CATHETER HUB BARREL AND COMPRESSION SPRING LOCATED INSIDE THE MYNX HANDLE.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.