Stent, Carotid
Basic Information
- Device Name
- Stent, Carotid
- Trade Name
- PROTEGE GPS AND PROTEGE RX CAROTID STENT SYSTEMS
- PMA Number
- P060001
- 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
- January 24, 2007
- Date Received
- January 9, 2006
- Expedited Review
- N
- Docket Number
- 07M-0049
Advisory Committee Statement
APPROVAL FOR THE PROTEGE GPS AND PROTEGE RX CAROTID STENT SYSTEMS. THIS DEVICE IS INDICATED FOR USED IN CONJUNCTION WITH EV3 EMBOLIC PROTECTION DEVICES, ARE INDICATED FOR THE TREATMENT OF PATIENTS AT HIGH RISK FOR ADVERSE EVENTS FROM CAROTID ENDARTERECTOMY WHO REQUIRE PERCUTANEOUS CAROTID REVASCULARIZATION AND MEET THE FOLLOWING CRITERIA:1) PATIENTS WITH CAROTID ARTERY STENOSIS (>= 50% FOR SYMPTOMATIC PATIENTS BY ULTRASOUND OR ANGIOGRAPHY OR >= 80% FOR ASYMPTOMATIC PATIENTS BY ULTRASOUND OR ANGIOGRAPHY) OF THE COMMON OR INTERNAL CAROTID ARTERY, AND2) PATIENTS MUST HAVE A REFERENCE VESSEL DIAMETER WITHIN THE RANGE OF 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 |