|
Device | FLAIR ENDOVASCULAR STENT GRAFT |
Generic Name | System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment |
Applicant | BARD PERIPHERAL VASCULAR 1625 W. THIRD ST TEMPE, AZ 85281 |
PMA Number | P060002 |
Supplement Number | S034 |
Date Received | 02/14/2014 |
Decision Date | 08/13/2014 |
Withdrawal Date
|
09/12/2022 |
Product Code |
PFV |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - PAS |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR UPDATED INSTRUCTIONS FOR USE (IFU) TO INCLUDE DATA FROM THE POSTAPPROVAL STUDY (RENOVA). |
Post-Approval Study | Show Report Schedule and Study Progress |