CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS

FDA premarket approval P050019 · decided 2008-10-23

Approval details

PMA number

P050019

Trade name

CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS

Generic name

Stent, carotid

Applicant

Boston Scientific Corp

Date received

2005-05-24

Decision date

2008-10-23

Days to decision

1248 days

Decision code

APPR

Product code

NIM

Advisory committee

Cardiovascular

Expedited review

No

Location

Maple Grove, MN

Statement

APPROVAL FOR THE CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS. THE DEVICE, USED INCONJUNCTION WITH THE BOSTON SCIENTIFIC EMBOLIC PROTECTION SYSTEM, IS INDICATED FOR THE TREATMENTOF PATIENTS AT HIGH RISK FOR ADVERSE EVENTS FROM CAROTID ENDARTERECTOMY DUE TO EITHER ANATOMIC OR COMORBID CONDITIONS WHO REQUIRE CAROTID REVASCULARIZATION IN THE TREATMENT OF IPSILATERAL ORBILATERAL CAROTID ARTERY DISEASE AND MEET THE CRITERIA OUTLINED BELOW:1) PATIENTS WITH NEUROLOGICAL SYMPTOMS AND > 50% STENOSIS OF THE

510(k) clearances by this applicant