|
Device | Venovo Venous Stent System |
Generic Name | Stent, iliac vein |
Applicant | Bard Peripheral Vascular, Inc. 1625 West Third Street Tempe, AZ 85281 |
PMA Number | P180037 |
Date Received | 09/14/2018 |
Decision Date | 03/13/2019 |
Product Code |
QAN |
Docket Number | 19M-1214 |
Notice Date | 03/14/2019 |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT02655887
|
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement Approval for the Venovo Venous Stent System. The device is indicated for the treatment of symptomatic iliofemoral venous outflow obstruction. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |
Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 S012 |