• 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

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
Generic Namestent, superficial femoral artery
3033 campus drive
plymouth, MN 55441
PMA NumberP000033
Date Received08/03/2000
Decision Date04/03/2002
Product Code
NIP[ Registered Establishments with NIP ]
Docket Number 02M-0235
Notice Date 05/24/2002
Advisory Committee Cardiovascular
Expedited Review Granted? Yes
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
Approval for the intracoil self-expanding peripheral stent. This device is indicated for improving peripheral luminal diameter in patients with symptomatic atherosclerotic disease due to stenotic lesions (length <= 15 cm) or occlusive lesions (length <= 12 cm) in femoropopliteal arteries, to the bifurcation of the tibial artery, with a reference vessel diameter of 3. 0 to 7. 8 mm.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002