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.
 
DeviceLIFESTAR VASCULAR STENT SYSTEMS
Generic NameSTENT, ILIAC
ApplicantBard Peripheral Vascular, Inc.
1415 W. 3rd St.
Tempe, AZ 85281
PMA NumberP080007
Supplement NumberS007
Date Received09/26/2011
Decision Date11/16/2011
Product Code NIO 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR REMOVAL OF THE PCRFORMAXX GRIP ON THE DELIVERY SYSTEM, THE ADDITION OF A SMALLER PACKAGING CONFIGURATION, AND MINOR LABELING CHANGES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LIFESTAR VASCULAR STENT SYSTEM AND IS INDICATED FOR THE TREATMENT OF ILIAC OCCLUSIVE DISEASE IN PATIENTS WITH SYMPTOMATIC VASCULAR DISEASE OF THE COMMON AND/OR EXTERNAL ILIAC ARTERIES UP TO 126 MM IN LENGTH WITH A REFERENCE VESSEL DIAMETER OF 5 TO 9 MM.
-
-