|
Device | Esprit™ BTK Everolimus Eluting Resorbable Scaffold System |
Generic Name | Stent, infrapopliteal, absorbable |
Applicant | Abbott Medical 3200 Lakeside Drive Santa Clara, CA 95054 |
PMA Number | P230036 |
Date Received | 10/31/2023 |
Decision Date | 04/26/2024 |
Product Code |
NXW |
Docket Number | 24M-2122 |
Notice Date | 05/06/2024 |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT04227899
|
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement The Esprit™ BTK Everolimus Eluting Resorbable Scaffold System is indicated for improving luminal diameter in infrapopliteal lesions in patients with Chronic Limb Threatening Ischemia (CLTI) and total scaffolding length up to 170 mm with a reference vessel diameter of >= 2.5 mm and <= 4.00 mm. |
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 |