PMA P230036S004
- Device
- ESPRIT™ BTK Everolimus Eluting Bioresorbable Scaffold System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P230036
- Supplement
- S004
- Product code
- NXW
- Decision date
- 2024-08-23
- Classification
- Cardiovascular
- Generic name
- Scaffold, infrapopliteal, absorbable
- Approval order statement
- to extend the device shelf life from 12 months to 18 months
Current openFDA PMA Record#
- Device
- ESPRIT™ BTK Everolimus Eluting Bioresorbable Scaffold System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P230036
- Supplement
- S004
- Product code
- NXW
- Generic name
- Scaffold, infrapopliteal, absorbable
- Decision date
- 2024-08-23
- Decision code
- APPR
- Date received
- 2024-06-03
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- to extend the device shelf life from 12 months to 18 months