ENROUTE TRANSCAROTID STENT SYSTEM
FDA premarket approval P140026 · decided 2015-05-18
Approval details
- PMA number
- P140026
- Trade name
- ENROUTE TRANSCAROTID STENT SYSTEM
- Generic name
- Stent, carotid
- Applicant
- Boston Scientific Corporation
- Date received
- 2014-11-17
- Decision date
- 2015-05-18
- Days to decision
- 182 days
- Decision code
- APPR
- Product code
- NIM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Marborough, MA
- Statement
- APPROVAL FOR THE ENROUTE TRANSCAROTID STENT SYSTEM. THIS DEVICE IS INDICATED FOR USE IN CONJUNCTION WITH THE ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM (NPS) FOR THE TREATMENT OF PATIENTS AT HIGH RISKFOR 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
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