• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections

New Search Back to Search Results
Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Namestent, superficial femoral artery
PMA NumberP120002
Date Received02/03/2012
Decision Date11/07/2012
Product Code
NIP[ Registered Establishments with NIP ]
Docket Number 12M-1183
Notice Date 12/05/2012
Advisory Committee Cardiovascular
Clinical Trials NCT00739102
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
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.
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S003 S004 S005 S006 S008 S010