PMA P230036S012
- Device
- Esprit™ BTK Everolimus Eluting Resorbable Scaffold System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P230036
- Supplement
- S012
- Product code
- NXW
- Decision date
- 2025-07-25
- Classification
- Cardiovascular
- Generic name
- Scaffold, infrapopliteal, absorbable
- Approval order statement
- to remove an in-process moisture content inspection step for tube extrusion
Current openFDA PMA Record#
- Device
- Esprit™ BTK Everolimus Eluting Resorbable Scaffold System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P230036
- Supplement
- S012
- Product code
- NXW
- Generic name
- Scaffold, infrapopliteal, absorbable
- Decision date
- 2025-07-25
- Decision code
- OK30
- Date received
- 2025-07-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to remove an in-process moisture content inspection step for tube extrusion