MYNX VASCULAR CLOSURE DEVICE PRODUCT FAMILY
FDA premarket approval P040044/S039 · decided 2012-02-13
Approval details
- PMA number
- P040044
- Supplement
- S039
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MYNX VASCULAR CLOSURE DEVICE PRODUCT FAMILY
- Generic name
- Device, hemostasis, vascular
- Applicant
- Cordis US Corporation
- Date received
- 2011-08-29
- Decision date
- 2012-02-13
- Days to decision
- 168 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- APPROVAL FOR MODIFICATIONS TO YOUR BALLOON TUBE NECKING PROCESS.
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