PMA P230036
- Device
- Esprit™ BTK Everolimus Eluting Resorbable Scaffold System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P230036
- Supplement
- S020
- Product code
- NXW
- Decision date
- 2026-09-24
- Classification
- Cardiovascular
- Generic name
- Scaffold, infrapopliteal, absorbable
- Approval order statement
- addition of in-process scaffold dimensional inspections for the Esprit BTK LL System
Current openFDA PMA Record#
- Device
- Esprit™ BTK Everolimus Eluting Resorbable Scaffold System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P230036
- Supplement
- S020
- Product code
- NXW
- Generic name
- Scaffold, infrapopliteal, absorbable
- Decision date
- 2026-09-24
- Decision code
- APPR
- Date received
- 2026-08-25
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- addition of in-process scaffold dimensional inspections for the Esprit BTK LL System