|
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 |
Date Received | 01/17/2006 |
Decision Date | 07/23/2007 |
Withdrawal Date
|
09/12/2022 |
Product Code |
PFV |
Docket Number | 07M-0298 |
Notice Date | 08/01/2007 |
Advisory Committee |
Cardiovascular |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE FLAIR ENDOVASCULAR STENT GRAFT. THE DEVICE IS INDICATED FOR USE IN THE TREATMENT OF STENOSES AT THE VENOUS ANASTOMOSIS OF EPTFE OR OTHER SYNTHETIC ARTERIOVENOUS (AV) ACCESS GRAFTS. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
|
Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S030 S020 S021 S027 S017 S026 S023 S033 S005 S001 S038 S025 S028 S031 S032 S022 S034 S024 S029 S036 S035 S002 S004 S006 S013 S014 S015 S016 S003 S010 S011 S007 S008 S009 S039 S040 |