Minima Stent System
FDA premarket approval P240003/S001 · decided 2024-11-08
Approval details
- PMA number
- P240003
- Supplement
- S001
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- Minima Stent System
- Generic name
- Aortic stent
- Applicant
- Renata Medical, Inc.
- Date received
- 2024-09-23
- Decision date
- 2024-11-08
- Days to decision
- 46 days
- Decision code
- APPR
- Product code
- PNF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Newport Beach, CA
- Statement
- Approval for the revised protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P240003.
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