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.
 
DeviceFLAIR ENDOVASCULAR STENT GRAFT WITH OPTIMIZED DELIVERY SYSTEM
Generic NameSystem, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
ApplicantBARD PERIPHERAL VASCULAR
1625 W. THIRD ST
TEMPE, AZ 85281
PMA NumberP060002
Supplement NumberS002
Date Received03/20/2008
Decision Date10/28/2008
Withdrawal Date 09/12/2022
Product Code PFV 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE OPTIMIZED DELIVERY SYSTEM, THE TRANSFER OF MANUFACTURING OF THE DELIVERY SYSTEM TO ANGIOMED GMBH & CO., KARLSRUHE, GERMANY, AND THE TRANSFER OF STERILIZATION TO BARD MEDICAL DIVISION REGIONAL STERILIZATION AND REGIONAL STERILIZATION MADISON OPERATION, IN COVINGTON, GEORGIA, AND MADISON, GEORGIA, RESPECTIVELY.
-
-