MYNXGRIP VASCULAR CLOSURE DEVICES
FDA premarket approval P040044/S059 · decided 2015-08-03
Approval details
- PMA number
- P040044
- Supplement
- S059
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MYNXGRIP VASCULAR CLOSURE DEVICES
- Generic name
- Device, hemostasis, vascular
- Applicant
- Cordis US Corporation
- Date received
- 2014-11-12
- Decision date
- 2015-08-03
- Days to decision
- 264 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- APPROVAL FOR A NEW COEXTRUDED BALLOON SUBASSEMBLY OF THE MYNXGRIP VASCULAR CLOSURE DEVICE.
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