- Device
- Esprit™ BTK Everolimus Eluting Resorbable Scaffold System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P230036
- Supplement
- S007
- Product code
- NXW
- Generic name
- Scaffold, infrapopliteal, absorbable
- Decision date
- 2024-12-11
- Decision code
- APPR
- Date received
- 2024-08-19
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to qualify Sterigenics Radiation Technologies, LLC, San Diego (Sterigenics SD) as an alternative sterilization site