PMA P230036S006
- Device
- Esprit™ BTK Everolimus Eluting Resorbable Scaffold System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P230036
- Supplement
- S006
- Product code
- NXW
- Decision date
- 2024-08-28
- Classification
- Cardiovascular
- Generic name
- Scaffold, infrapopliteal, absorbable
- Approval order statement
- a change to the sampling plan for finished device in vitro engineering lot release and analytical lot release testing
Current openFDA PMA Record#
- Device
- Esprit™ BTK Everolimus Eluting Resorbable Scaffold System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P230036
- Supplement
- S006
- Product code
- NXW
- Generic name
- Scaffold, infrapopliteal, absorbable
- Decision date
- 2024-08-28
- Decision code
- OK30
- Date received
- 2024-08-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a change to the sampling plan for finished device in vitro engineering lot release and analytical lot release testing