PMA P240003
- Device
- Minima Stent System
- Applicant
- Renata Medical, Inc.
- Product code
- PNF
- Decision date
- 2026-02-11
- Generic name
- Aortic stent
- Approval order statement
- a change to a process inspection acceptance criterion for the balloon shaft of the Minima Stent System
Current openFDA PMA Record#
- Device
- Minima Stent System
- Applicant
- Renata Medical, Inc.
- PMA number
- P240003
- Supplement
- S007
- Product code
- PNF
- Generic name
- Aortic stent
- Decision date
- 2026-02-11
- Decision code
- OK30
- Date received
- 2026-01-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a change to a process inspection acceptance criterion for the balloon shaft of the Minima Stent System