MYNX VASCULAR CLOSURE DEVICE
FDA premarket approval P040044/S008 · decided 2008-07-22
Approval details
- PMA number
- P040044
- Supplement
- S008
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MYNX VASCULAR CLOSURE DEVICE
- Generic name
- Device, hemostasis, vascular
- Applicant
- Cordis US Corporation
- Date received
- 2008-06-03
- Decision date
- 2008-07-22
- Days to decision
- 49 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- APPROVAL FOR CHANGING THE METHOD OF ATTACHMENT OF THE TENSION PLUNGER TO THE COREWIRE OF THE MYNX VASCULAR CLOSURE DEVICE TO OVERMOLD THE TENSION PLUNGER DIRECTLY ONTO THE COREWIRE.
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