MYNX ACE VASCULAR CLOSURE DEVICE (6F/7F)
FDA premarket approval P040044/S047 · decided 2013-08-19
Approval details
- PMA number
- P040044
- Supplement
- S047
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MYNX ACE VASCULAR CLOSURE DEVICE (6F/7F)
- Generic name
- Device, hemostasis, vascular
- Applicant
- Cordis US Corporation
- Date received
- 2012-12-31
- Decision date
- 2013-08-19
- Days to decision
- 231 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- APPROVAL FOR MODIFICATIONS TO THE DELIVERY SYSTEM THAT COMPOSES THE MYNXGRIP VASCULAR CLOSURE DEVICE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MYNX ACE VASCULAR CLOSURE DEVICE ("MYNX ACE") AND IS INDICATED FOR USE TO SEAL FEMORAL ARTERIALACCESS SITES WHILE REDUCING TIMES TO HEMOSTASIS AND AMBULATION IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL ENDOVASCULAR PROCEDURES UTILIZING A 5F, 6F OR 7F PROCEDURAL SHEATH.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.