Stent, Carotid
Basic Information
- Device Name
- Stent, Carotid
- Trade Name
- EXPONENT SELF-EXPANDING CAROTID STENT SYSTEM WITH OVER-THE-WIRE OR RAPID-EXCHANGE DELIVERY SYSTEM
- PMA Number
- P070012
- Device Class
- FDA Class 3
- Product Code
- NIM
- Generic Name
- Stent, carotid
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved (Withdrawn)
- Decision Code
- APWD
- Decision Date
- October 23, 2007
- Date Received
- April 30, 2007
- Expedited Review
- N
- Docket Number
- 07M-0411
Advisory Committee Statement
APPROVAL FOR THE EXPONENT SELF-EXPANDING CAROTID STENT SYSTEM WITH OVER-THE-WIRE OR RAPID-EXCHANGE DELIVERY SYSTEM. THE DEVICE IS INDICATED FOR USE, IN CONJUNCTION WITH A MEDTRONIC VASCULAR EMBOLIC PROTECTION SYSTEM, FOR IMPROVING CAROTID LUMINAL DIAMETER IN 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 EITHER ULTRASOUND OR ANGIOGRAM, OR PATIENTS WITHOUT NEUROLOGICAL SYMPTOMS AND >=80% STENOSIS OF THE COMMON OR INTERNAL CAROTID ARTERY BY EITHER ULTRASOUND OR ANGIOGRAM; AND 2) PATIENTS HAVING A VESSEL WITH REFERENCE DIAMETERS BETWEEN 4.5 MM AND 9.5 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 |