ANGIOLINK VASCULAR CLOSURE SYSTEM
FDA premarket approval P040022 · decided 2004-11-03
Approval details
- PMA number
- P040022
- Trade name
- ANGIOLINK VASCULAR CLOSURE SYSTEM
- Generic name
- Device, hemostasis, vascular
- Applicant
- Medtronic Vascular
- Date received
- 2004-04-26
- Decision date
- 2004-11-03
- Days to decision
- 191 days
- Decision code
- APWD
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Danvers, MA
- Statement
- APPROVAL FOR THE EVS VASCULAR CLOSURE SYSTEM. THE DEVICE IS INDICATED FOR PERCUTANEOUS FEMORAL ARTERY APPROXIMATION. THE EVS VASCULAR CLOSURE SYSTEM IS ALSO INDICATED TO REDUCE TIME TO HEMOSTASIS AT FEMORAL PUNCTURE SITES AND TO REDUCE TIME TO AMBULATION FOR PATIENTS UNDERGOING DIAGNOSTIC AND INTERVENTIONAL CATHETERIZATION PROCEDURES USING 6-8 FRENCH PROCEDURAL SHEATHS.
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