Stent, Carotid
Basic Information
- Device Name
- Stent, Carotid
- Trade Name
- XACT CAROTID STENT SYSTEM
- PMA Number
- P040038
- 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
- September 6, 2005
- Date Received
- September 3, 2004
- Expedited Review
- N
- Docket Number
- 05M-0381
Advisory Committee Statement
APPROVAL FOR THE XACT CAROTID STENT SYSTEM. THE XACT CAROTID STENT SYSTEM, USED IN CONJUNCTION WITH THE ABBOTT VASCULAR DEVICES EMBOLIC PROTECTION SYSTEM, IS INDICATED FOR THE IMPROVEMENT OF THE LUMEN DIAMETER OF CAROTID ARTERIES IN PATIENTS CONSIDERED AT HIGH RISK FOR ADVERSE EVENTS FROM CAROTID ENDARTERECTOMY WHO REQUIRE PERCUTANEOUS CAROTID ANGIOPLASTY AND STENTING FOR OCCLUSIVE ARTERY DISEASE AND MEET THE CRITERIA OUTLINED AS FOLLOWS: 1) PATIENTS WITH CAROTID ARTERY STENOSIS (>= 50% FOR SYMPTOMATIC PATIENTS BY ULTRASOUND OR ANGIOGRAPHY OR >= 80% FOR ASYMPTOMATIC PATIENTS BY ULTRASOUND OR ANGIOGRAPHY), LOCATED BETWEEN THE ORIGIN OF THE COMMON CAROTID ARTERY AND THE INTRA-CRANIAL SEGMENT OF THE INTERNAL CAROTID ARTERY; AND 2) PATIENTS MUST HAVE A REFERENCE VESSEL DIAMETER RANGING BETWEEN 4.8 MM AND 9.1 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 |