CORDIS PRECISE NITINOL STENT SYSTEM
FDA premarket approval P030047 · decided 2006-09-22
Approval details
- PMA number
- P030047
- Trade name
- CORDIS PRECISE NITINOL STENT SYSTEM
- Generic name
- Stent, carotid
- Applicant
- Cordis US Corporation
- Date received
- 2003-10-08
- Decision date
- 2006-09-22
- Days to decision
- 1080 days
- Decision code
- APPR
- Product code
- NIM
- Advisory committee
- Cardiovascular
- Expedited review
- Yes
- Location
- Miami Lakes, FL
- Statement
- APPROVAL FOR THE CORDIS PRECISE NITINOL STENT SYSTEM (5.5 FR AND 6.0 FR SIZES, OVER-THE-WIRE CONFIGURATION). THIS DEVICE IS INDICATED FOR USE IN CONJUNCTION WITH THE ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE FOR THE TREATMENT OF PATIENTS AT HIGH RISK FOR ADVERSE EVENTS FROM CAROTID ENDARTERECTOMY (DEFINED IN THE IFU) WHO REQUIRE CAROTID REVASCULARIZATION AND MEET THE CRITERIA OUTLINED BELOW: 1) PATIENTS WITH NEUROLOGICAL SYMPTOMS AND >=50% STENOSIS OF THE COMMON OR INTERNAL CAROTID ARTERY BY ULTRAS
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