MATRIX VASCULAR CLOSURE SYSTEM (VSG)
FDA premarket approval P040044 · decided 2005-08-17
Approval details
- PMA number
- P040044
- Trade name
- MATRIX VASCULAR CLOSURE SYSTEM (VSG)
- Generic name
- Device, hemostasis, vascular
- Applicant
- Cordis US Corporation
- Date received
- 2004-11-04
- Decision date
- 2005-08-17
- Days to decision
- 286 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- APPROVAL FOR THE MATRIX VSG SYSTEM, MODEL MX-100. THE DEVICE 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.
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