PMA P230036S008
- Device
- ESPRIT™ BTK Everolimus Eluting Bioresorbable Scaffold System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P230036
- Supplement
- S008
- Product code
- NXW
- Decision date
- 2024-12-18
- Classification
- Cardiovascular
- Generic name
- Scaffold, infrapopliteal, absorbable
- Approval order statement
- approval for a shelf-life extension to 24 months
Current openFDA PMA Record#
- Device
- ESPRIT™ BTK Everolimus Eluting Bioresorbable Scaffold System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P230036
- Supplement
- S008
- Product code
- NXW
- Generic name
- Scaffold, infrapopliteal, absorbable
- Decision date
- 2024-12-18
- Decision code
- APPR
- Date received
- 2024-11-01
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- approval for a shelf-life extension to 24 months