MYNXGRIP VASCULAR CLOSURE DEVICE
FDA premarket approval P040044/S075 · decided 2017-06-28
Approval details
- PMA number
- P040044
- Supplement
- S075
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MYNXGRIP VASCULAR CLOSURE DEVICE
- Generic name
- Device, hemostasis, vascular
- Applicant
- Cordis US Corporation
- Date received
- 2016-11-21
- Decision date
- 2017-06-28
- Days to decision
- 219 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- Approval to implement process improvements for the balloon to catheter bonds.
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