MynxGrip Vascular Closure Device
FDA premarket approval P040044/S077 · decided 2017-09-28
Approval details
- PMA number
- P040044
- Supplement
- S077
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MynxGrip Vascular Closure Device
- Generic name
- Device, hemostasis, vascular
- Applicant
- Cordis US Corporation
- Date received
- 2017-06-30
- Decision date
- 2017-09-28
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- Approval to implement minor modifications to the MynxGrip Vascular Closure Device desiccant canister and desiccant canister cavity within the device packaging tray.
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