MYNX VASCULAR CLOSURE DEVICE
FDA premarket approval P040044/S004 · decided 2007-12-17
Approval details
- PMA number
- P040044
- Supplement
- S004
- Supplement type
- Special (Immediate Track)
- 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
- 2007-11-16
- Decision date
- 2007-12-17
- Days to decision
- 31 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- APPROVAL FOR AN ADDITIONAL INSPECTION STEP IN THE MANUFACTURING AND TESTING PROCESS FOR THE DEVICE.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.