Minima Stent System
FDA premarket approval P240003/S005 · decided 2025-12-18
Approval details
- PMA number
- P240003
- Supplement
- S005
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Minima Stent System
- Generic name
- Aortic stent
- Applicant
- Renata Medical, Inc.
- Date received
- 2025-09-30
- Decision date
- 2025-12-18
- Days to decision
- 79 days
- Decision code
- OK30
- Product code
- PNF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Newport Beach, CA
- Statement
- to move the dimensional inspection of the Minima Stent from a receiving step at the system assembly contract manufacturer, Medical Murray, to an outgoing inspection at the Minima Stent Manufacturer, Meko Laser
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.