PMA P240003S004
- Device
- Minima Stent System
- Applicant
- Renata Medical, Inc.
- PMA number
- P240003
- Supplement
- S004
- Product code
- PNF
- Decision date
- 2025-09-11
- Classification
- Cardiovascular
- Generic name
- Aortic stent
- Approval order statement
- Approval for updates to the Instructions for Use labeling, including additional precautions, intended to enhance the safe use of the Minima Stent System.
Current openFDA PMA Record#
- Device
- Minima Stent System
- Applicant
- Renata Medical, Inc.
- PMA number
- P240003
- Supplement
- S004
- Product code
- PNF
- Generic name
- Aortic stent
- Decision date
- 2025-09-11
- Decision code
- APPR
- Date received
- 2025-08-13
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for updates to the Instructions for Use labeling, including additional precautions, intended to enhance the safe use of the Minima Stent System.