MYNXGRIP VASCULAR CLOSURE DEVICE (MYNXGRIP)
FDA premarket approval P040044/S066 · decided 2015-12-03
Approval details
- PMA number
- P040044
- Supplement
- S066
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- MYNXGRIP VASCULAR CLOSURE DEVICE (MYNXGRIP)
- Generic name
- Device, hemostasis, vascular
- Applicant
- Cordis US Corporation
- Date received
- 2015-09-09
- Decision date
- 2015-12-03
- Days to decision
- 85 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- APPROVAL FOR AN EXTENSION OF SHELF LIFE FROM ONE YEAR TO TWO YEARS.
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