CORDIS EXOSEAL VASCULAR CLOSURE DEVICE
FDA premarket approval P100013 · decided 2011-05-19
Approval details
- PMA number
- P100013
- Trade name
- CORDIS EXOSEAL VASCULAR CLOSURE DEVICE
- Generic name
- Device, hemostasis, vascular
- Applicant
- Cordis US Corporation
- Date received
- 2010-04-01
- Decision date
- 2011-05-19
- Days to decision
- 413 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- APPROVAL FOR THE EXOSEAL VASCULAR CLOSURE DEVICE. THIS DEVICE IS INDICATED AS FOLLOWS: THE EXOSEAL VASCULAR CLOSURE DEVICE (VCD) IS INDICATED FOR FEMORAL ARTERY PUNCTURE SITE CLOSURE, REDUCING TIMES TO HEMOSTASIS AND AMBULATION IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL CATHETERIZATION PROCEDURES USING A STANDARD 5F, 6F, OR 7F VASCULAR SHEATH INTRODUCER WITH UP TO 12 CM WORKING LENGTH. ADDITIONALLY, THE EXOSEAL VCD IS INDICATED TO REDUCE TIMES TO HEMOSTASIS AND AMBULATION IN PAT
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