Esprit BTK Everolimus Eluting Resorbable Scaffold System
FDA premarket approval P230036/S011 · decided 2025-06-27
Approval details
- PMA number
- P230036
- Supplement
- S011
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Esprit BTK Everolimus Eluting Resorbable Scaffold System
- Generic name
- Scaffold, infrapopliteal, absorbable
- Applicant
- ABBOTT MEDICAL
- Date received
- 2025-03-31
- Decision date
- 2025-06-27
- Days to decision
- 88 days
- Decision code
- APPR
- Product code
- NXW
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Clara, CA
- Statement
- the addition of an Over The Wire (OTW) delivery system version
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