SMA RT CONTROL AND SMART VASCULAR STENT SYSTEMS

Stent, Superficial Femoral Artery

FDA Premarket Approval P120002

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 s. M. A. R. T. Control and s. M. A. R. T. Vascular stent systems. This device is indicated for use to improve luminal diameter in the treatment of patients with de novo or restenotic native lesion(s) of the superficial femoral artery and/or proximal popliteal artery with total length up to 150 mm and with a reference vessel diameter ranging from 4 mm to 7 mm.

• Device: SMA RT CONTROL AND SMART VASCULAR STENT SYSTEMS
• Classification Name: Stent, Superficial Femoral Artery
• Generic Name: Stent, Superficial Femoral Artery
• Applicant: CORDIS CORP.
• Date Received: 2012-02-03
• Decision Date: 2012-11-07
• Notice Date: 2012-12-05
• PMA: P120002
• Supplement: S
• Product Code: NIP
• Docket Number: 12M-1183
• Advisory Committee: Cardiovascular
• Expedited Review: No
• Combination Product: No
• Applicant Address: CORDIS CORP. 6500 Paseo Padre Parkway fremont, CA 94555
• 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
P120002		Original Filing
S022	2022-11-07	30-day Notice
S021
S020	2021-09-01	Normal 180 Day Track
S019	2021-03-03	30-day Notice
S018	2020-09-25	30-day Notice
S017	2020-05-01	30-day Notice
S016	2019-05-24	30-day Notice
S015	2019-04-01	30-day Notice
S014	2018-12-03	30-day Notice
S013	2018-02-26	30-day Notice
S012	2016-03-21	30-day Notice
S011	2015-10-05	30-day Notice
S010	2015-05-01	30-day Notice
S009	2015-03-19	135 Review Track For 30-day Notice
S008	2015-03-18	30-day Notice
S007	2015-03-11	Normal 180 Day Track No User Fee
S006	2014-12-19	Normal 180 Day Track No User Fee
S005	2014-09-23	30-day Notice
S004	2014-05-12	30-day Notice
S003	2014-04-16	30-day Notice
S002
S001	2014-03-24	30-day Notice

NIH GUDID Devices

Device ID	PMA	Supp
20705032082362	P120002	000
20705032082430	P120002	000
20705032082539	P120002	000
20705032082614	P120002	000
20705032082638	P120002	000
20705032082645	P120002	000
20705032082652	P120002	000
20705032082683	P120002	000
20705032024478	P120002	000
20705032024997	P120002	000
20705032025017	P120002	000
20705032025031	P120002	000
20705032025055	P120002	000
20705032063385	P120002	004
20705032063392	P120002	004
20705032063408	P120002	004
20705032063415	P120002	004
20705032063422	P120002	004
20705032063439	P120002	004