Mynx Control Vascular Closure Device (5F, 6F/7F), MynxGrip Vascular Closure Device (5F, 6F/7F)
FDA premarket approval P040044/S100 · decided 2024-03-21
Approval details
- PMA number
- P040044
- Supplement
- S100
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Mynx Control Vascular Closure Device (5F, 6F/7F), MynxGrip Vascular Closure Device (5F, 6F/7F)
- Generic name
- Device, hemostasis, vascular
- Applicant
- Cordis US Corporation
- Date received
- 2024-02-22
- Decision date
- 2024-03-21
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- relocation of your supplier's finishing steps for the tubing component to a different building within the same registered facility
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