MYNXGRIP VASCULAR CLOSURE DEVICE (5F, 6F/7F)
FDA premarket approval P040044/S068 · decided 2016-09-06
Approval details
- PMA number
- P040044
- Supplement
- S068
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MYNXGRIP VASCULAR CLOSURE DEVICE (5F, 6F/7F)
- Generic name
- Device, hemostasis, vascular
- Applicant
- Cordis US Corporation
- Date received
- 2015-12-07
- Decision date
- 2016-09-06
- Days to decision
- 274 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 9020 Activity Road, Suite D, San Diego, California, 92126 for the sterilization of the Mynx Grip Vascular Closure Device (5F/6F/7F) and Mynx Ace Vascular Closure Device (5F/6F/7F).
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