MYNX VASCULAR CLOSURE DEVICE
FDA premarket approval P040044/S005 · decided 2008-05-16
Approval details
- PMA number
- P040044
- Supplement
- S005
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MYNX VASCULAR CLOSURE DEVICE
- Generic name
- Device, hemostasis, vascular
- Applicant
- Cordis US Corporation
- Date received
- 2008-03-11
- Decision date
- 2008-05-16
- Days to decision
- 66 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- APPROVAL FOR THE FOLLOWING CHANGES TO THE MANUFACTURING PROCESSES: 1) REPLACING THE HEATED DIE NECKER MACHINE WITH A HOT AIR NECKER MACHINE; AND 2) REPLACING THE GLASS MOLD BALOON BLOWER MACHINE WITH A METAL MOLD BALLOON BLOWER MACHINE.
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