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Device | LIFESTREAM BALLOON EXPANDABLE VASCULAR COVERED STENT |
Generic Name | Iliac covered stent, arterial |
Applicant | BARD PERIPHERAL VASCULAR, INC. 1625 WEST 3RD ST. TEMPE, AZ 85281-1740 |
PMA Number | P160024 |
Date Received | 07/21/2016 |
Decision Date | 04/24/2017 |
Product Code |
PRL |
Docket Number | 17M-2594 |
Notice Date | 04/25/2017 |
Advisory Committee |
Cardiovascular |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement Approval for the LifeStream Balloon Expandable Vascular Covered Stent. This device is indicated for the treatment of atherosclerotic lesions in common and external iliac arteries with reference vessel diameters between 4.5 mm and 12.0 mm, and lesion lengths up to 100 mm. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
|
Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 S012 |