MYNX VASCULAR CLOSURE DEVICE
FDA premarket approval P040044/S012 · decided 2009-04-15
Approval details
- PMA number
- P040044
- Supplement
- S012
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- MYNX VASCULAR CLOSURE DEVICE
- Generic name
- Device, hemostasis, vascular
- Applicant
- Cordis US Corporation
- Date received
- 2009-03-19
- Decision date
- 2009-04-15
- Days to decision
- 27 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- APPROVAL FOR MODIFYING THE INSTRUCTIONS FOR USE TO INCLUDE THE USE OF 50% CONTRAST MEDIA / 50% SALINE SOLUTION FOR INFLATING THE BALLOON CATHETER.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.