Minima Stent System
FDA premarket approval P240003/S004 · decided 2025-09-11
Approval details
- PMA number
- P240003
- Supplement
- S004
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Minima Stent System
- Generic name
- Aortic stent
- Applicant
- Renata Medical, Inc.
- Date received
- 2025-08-13
- Decision date
- 2025-09-11
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- PNF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Newport Beach, CA
- Statement
- Approval for updates to the Instructions for Use labeling, including additional precautions, intended to enhance the safe use of the Minima Stent System.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.