Mynx Control Vascular Closure Device
FDA premarket approval P040044/S079 · decided 2018-09-10
Approval details
- PMA number
- P040044
- Supplement
- S079
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Mynx Control Vascular Closure Device
- Generic name
- Device, hemostasis, vascular
- Applicant
- Cordis US Corporation
- Date received
- 2018-02-05
- Decision date
- 2018-09-10
- Days to decision
- 217 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- Approval for modifications to the delivery system handle and changes to the delivery system component materials.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.