MYNX VASCULAR CLOSURE DEVICE
FDA premarket approval P040044/S045 · decided 2013-07-22
Approval details
- PMA number
- P040044
- Supplement
- S045
- 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
- 2012-11-14
- Decision date
- 2013-07-22
- Days to decision
- 250 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED IN SANTA CLARA, CALIFORNIA.
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