• 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.
 
DeviceINTRA COIL SELF-EXPANDING PERIPHERAL STENT
Classification Namestent, superficial femoral artery
Generic Namestent, superficial femoral artery
Applicant
MEDTRONIC VASCULAR INC
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 
-
-