PMA P230036S011
- Device
- Esprit™ BTK Everolimus Eluting Resorbable Scaffold System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P230036
- Supplement
- S011
- Product code
- NXW
- Decision date
- 2025-06-27
- Classification
- Cardiovascular
- Generic name
- Scaffold, infrapopliteal, absorbable
- Approval order statement
- the addition of an Over The Wire (OTW) delivery system version
Current openFDA PMA Record#
- Device
- Esprit™ BTK Everolimus Eluting Resorbable Scaffold System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P230036
- Supplement
- S011
- Product code
- NXW
- Generic name
- Scaffold, infrapopliteal, absorbable
- Decision date
- 2025-06-27
- Decision code
- APPR
- Date received
- 2025-03-31
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- the addition of an Over The Wire (OTW) delivery system version