MYNX CADENCE VASCULAR CLOSURE DEVICE

FDA premarket approval P040044/S037 · decided 2011-04-05

Approval details

PMA number

P040044

Supplement

S037

Supplement type

Real-Time Process

Supplement reason

Change Design/Components/Specifications/Material

Trade name

MYNX CADENCE VASCULAR CLOSURE DEVICE

Generic name

Device, hemostasis, vascular

Applicant

Cordis US Corporation

Date received

2011-03-10

Decision date

2011-04-05

Days to decision

26 days

Decision code

APPR

Product code

MGB

Advisory committee

Cardiovascular

Expedited review

No

Location

Miami Lakes, FL

Statement

APPROVAL FOR A MINOR DESIGN CHANGE TO MODIFY THE ADVANCER TUBE TO INCORPORATE A DUAL SLIT DESIGN AT THE PROXIMAL END OF THE ADVANCER TUBE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MYNX CADENCE VASCULAR CLOSURE DEVICE AND IS INDICATED FOR USE TO SEAL FEMORAL ARTERIAL ACCESS 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.