Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceLIFESTENT VASCULAR STENT SYSTEMS
Generic NameSTENT, SUPERFICIAL FEMORAL ARTERY
ApplicantBard Peripheral Vascular, Inc.
1415 W. 3rd St.
Tempe, AZ 85281
PMA NumberP070014
Supplement NumberS018
Date Received09/09/2010
Decision Date10/14/2010
Product Code NIP 
Advisory Committee Cardiovascular
Clinical TrialsNCT00673985
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A CHANGE IN LABELING THAT UPDATES THE INSTRUCTIONS FOR USE AND THE PATIENT INFORMATION BROCHURE TO INCLUDE THE MOST RECENT CLINICAL DATA UP TO 3 YEARS.
-
-