CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS

Stent, Carotid

FDA Premarket Approval P050019

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

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 common, internal carotidartery and/or the bifurcation by ultrasound or angiogram, or patients without neurologicalsymptoms and > 80% stenosis of the common, internal carotid artery and/or thebifurcation by ultrasound or angiogram, and;2) patients with a reference vessel diameter within the range of 4. 0 mm and 9. 0 mm at thetarget lesion.

• Device: CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS
• Classification Name: Stent, Carotid
• Generic Name: Stent, Carotid
• Applicant: Boston Scientific Corp.
• Date Received: 2005-05-24
• Decision Date: 2008-10-23
• Notice Date: 2008-12-01
• PMA: P050019
• Supplement: S
• Product Code: NIM
• Docket Number: 08M-0596
• Advisory Committee: Cardiovascular
• Expedited Review: No
• Combination Product: No
• Applicant Address: Boston Scientific Corp. three Scimed Place maple Grove, MN 55311-1566
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling
• Post-Approval Study: Show Report Schedule and Study Progress
• Approval Order: Approval Order

Supplemental Filings

Supplement Number	Date	Supplement Type
P050019		Original Filing
S036	2022-11-14	30-day Notice
S035
S034	2022-02-22	30-day Notice
S033	2021-11-12	30-day Notice
S032	2021-10-19	30-day Notice
S031	2019-06-27	30-day Notice
S030	2018-02-21	30-day Notice
S029	2018-01-26	30-day Notice
S028	2017-06-19	30-day Notice
S027
S026	2016-11-14	30-day Notice
S025	2016-07-13	30-day Notice
S024	2016-02-25	30-day Notice
S023	2015-11-20	30-day Notice
S022	2015-11-19	30-day Notice
S021	2015-02-23	Real-time Process
S020
S019	2013-09-27	30-day Notice
S018	2013-09-20	30-day Notice
S017	2013-08-29	30-day Notice
S016	2013-06-19	30-day Notice
S015	2013-06-10	30-day Notice
S014	2013-05-28	30-day Notice
S013	2013-02-04	30-day Notice
S012	2012-11-19	30-day Notice
S011	2012-11-01	30-day Notice
S010	2012-08-13	30-day Notice
S009	2012-06-13	30-day Notice
S008	2011-07-15	Normal 180 Day Track No User Fee
S007	2011-04-01	30-day Notice
S006	2010-10-07	Normal 180 Day Track No User Fee
S005	2010-04-08	135 Review Track For 30-day Notice
S004	2010-02-01	Normal 180 Day Track
S003	2010-01-26	30-day Notice
S002	2009-12-15	30-day Notice
S001	2009-05-19	Normal 180 Day Track No User Fee

NIH GUDID Devices

Device ID	PMA	Supp
08714729781226	P050019	000
08714729781202	P050019	000
08714729781189	P050019	000
08714729781165	P050019	000
08714729781141	P050019	000
08714729781127	P050019	000
08714729781103	P050019	000