Minima Stent System
FDA premarket approval P240003/S003 · decided 2025-03-11
Approval details
- PMA number
- P240003
- Supplement
- S003
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Minima Stent System
- Generic name
- Aortic stent
- Applicant
- Renata Medical, Inc.
- Date received
- 2025-02-10
- Decision date
- 2025-03-11
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- PNF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Newport Beach, CA
- Statement
- Approval for quality controls in the manufacturing process that add a minimum fillet size specification and a maximum length specification to provide additional assurance of strength and reliability of the Minima Stent System.
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