MYNX VASCULAR CLOSURE DEVICE
FDA premarket approval P040044/S007 · decided 2008-12-14
Approval details
- PMA number
- P040044
- Supplement
- S007
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MYNX VASCULAR CLOSURE DEVICE
- Generic name
- Device, hemostasis, vascular
- Applicant
- Cordis US Corporation
- Date received
- 2008-03-31
- Decision date
- 2008-12-14
- Days to decision
- 258 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT NUTEK CORPORATION OF CALIFORNIA, HAYWARD, CALIFORNIA, FOR E-BEAM STERILIZATION.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.