MATRIX VASCULAR CLOSURE SYSTEM (VSG)
FDA premarket approval P040044/S072 · decided 2016-05-04
Approval details
- PMA number
- P040044
- Supplement
- S072
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MATRIX VASCULAR CLOSURE SYSTEM (VSG)
- Generic name
- Device, hemostasis, vascular
- Applicant
- Cordis US Corporation
- Date received
- 2016-04-04
- Decision date
- 2016-05-04
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- Modify the balloon material resin of the MynxAce balloon catheter.
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