• 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 record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DeviceLIFESTENT AND LIFESTENT XL VASCULAR STENT SYSTEMS
Classification Namestent, superficial femoral artery
Generic Namestent, superficial femoral artery
Applicant
BARD PERIPHERAL VASCULAR, INC.
1415 west 3rd st.
tempe, AZ 85281
PMA NumberP070014
Supplement NumberS010
Date Received03/10/2010
Decision Date12/23/2010
Product Code
NIP[ Registered Establishments with NIP ]
Docket Number 11M-0039
Notice Date 01/25/2011
Advisory Committee Cardiovascular
Clinical Trials NCT00673985
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the lifestent and lifestent xl vascular stent systems. The lifestent and lifestent xl vascular stent systems are intended to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions up to 240 mm in length in native superficial femoral artery (sfa) and/or proximal popliteal arteries with reference vessel diameters ranging from 4. 0 ¿ 6. 5 mm.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
-
-