Esprit BTK Everolimus Eluting Resorbable Scaffold System
FDA premarket approval P230036 · decided 2024-04-26
Approval details
- PMA number
- P230036
- Trade name
- Esprit BTK Everolimus Eluting Resorbable Scaffold System
- Generic name
- Scaffold, infrapopliteal, absorbable
- Applicant
- ABBOTT MEDICAL
- Date received
- 2023-10-31
- Decision date
- 2024-04-26
- Days to decision
- 178 days
- Decision code
- APPR
- Product code
- NXW
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Clara, CA
- 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.
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