Data / Medical devices / United States / Renata Medical
Renata Medical: FDA-registered device maker in Newport Beach, CA, United States, 1 PMA approval
Renata Medical is registered with the FDA (registration 3027098402) in Newport Beach, CA, United States. It lists 2 device types. The FDA files 1 PMA approval under its listings, the newest dated August 28, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3027098402
- Address
- 4675 Macarthur Ct Ste 1150, Newport Beach, CA, United States, 92660
- Owner or operator
- Renata Medical (10089373)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- August 30, 2024
- Registered through
- 2026
- Brand names listed
- Minima, Minima Growth Stent, Minima Stent, Minima Stent System, Minima System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Aortic Stent | PNF | 3 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Pulmonary Stent | QWC | 3 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| August 28, 2024 | P240003 | Minima Stent System and Minima Pro Stent System | PNF | 8 | August 27, 2026 | accessdata.fda.gov |
Compare with other makers
Updated August 27, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.