MYNX VASCULAR CLOSURE DEVICE PRODUCT FAMILY
FDA premarket approval P040044/S038 · decided 2011-07-21
Approval details
- PMA number
- P040044
- Supplement
- S038
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MYNX VASCULAR CLOSURE DEVICE PRODUCT FAMILY
- Generic name
- Device, hemostasis, vascular
- Applicant
- Cordis US Corporation
- Date received
- 2011-05-27
- Decision date
- 2011-07-21
- Days to decision
- 55 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- APPROVAL FOR A CONTRACT STERILIZATION SITE, BEAMONE, LLC LOCATED IN MOUNTAIN VIEW, CALIFORNIA.
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