MynxGrip Vascular Closure Device
FDA premarket approval P040044/S081 · decided 2018-07-10
Approval details
- PMA number
- P040044
- Supplement
- S081
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MynxGrip Vascular Closure Device
- Generic name
- Device, hemostasis, vascular
- Applicant
- Cordis US Corporation
- Date received
- 2018-05-16
- Decision date
- 2018-07-10
- Days to decision
- 55 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- Approval to add Steri-Tek (Smart World LLC) located at 48225 Lakeview Boulevard, Fremont, California 94538, as a new E-beam sterilization site for the MynxGrip Vascular Closure Device (5F/6F/7F).
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