Stent, Carotid
Basic Information
- Device Name
- Stent, Carotid
- Trade Name
- ACCULINK CAROTID STENT SYSTEM AND RX ACCULINK CAROTID STENT SYSTEM
- PMA Number
- P040012
- Device Class
- FDA Class 3
- Product Code
- NIM
- Generic Name
- Stent, carotid
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- August 30, 2004
- Date Received
- March 15, 2004
- Expedited Review
- Y
- Docket Number
- 04M-0388
Advisory Committee Statement
APPROVAL FOR THE ACCULINK CAROTID STENT SYSTEM AND RX ACCULINK CAROTID STENT SYSTEM. THE ACCULINK CAROTID STENT SYSTEM AND THE RX ACCULINK CAROTID STENT SYSTEM, USED IN CONJUNCTION WITH GUIDANT CAROTID EMBOLIC PROTECTION SYSTEMS, ARE INDICATED FOR THE TREATMENT OF PATIENTS AT HIGH RISK FOR ADVERSE EVENTS FROM CAROTID ENDARTERECTOMY 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 ULTRASOUND OR ANGIOGRAM OR PATIENTS WITHOUT NEUROLOGICAL SYMPTOMS AND >=80% STENOSIS OF THE COMMON OR INTERNAL CAROTID ARTERY BY ULTRASOUND OR ANGIOGRAM, AND2) PATIENTS MUST HAVE A REFERENCE VESSEL DIAMETER WITHIN THE RANGE OF 4.0 MM AND 9.0 MM AT THE TARGET LESION.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NIM | Stent, Carotid | FDA class 3 | Unknown |