Minima Stent System
FDA premarket approval P240003/S002 · decided 2025-01-16
Approval details
- PMA number
- P240003
- Supplement
- S002
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Minima Stent System
- Generic name
- Aortic stent
- Applicant
- Renata Medical, Inc.
- Date received
- 2024-11-05
- Decision date
- 2025-01-16
- Days to decision
- 72 days
- Decision code
- APPR
- Product code
- PNF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Newport Beach, CA
- Statement
- Approval for a shelf-life extension to 24 months for the Minima Stent System.
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