Renata Medical, Inc.: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Renata Medical, Inc.”, plus 1 PMA decision, across 1 product code in 1 review panel. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PNF | Aortic Stent | 1 | 0 |
Review panels
- Cardiovascular (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P240003 | PMA | Minima Stent System | 2024-08-28 |
Recalls
openFDA lists no recalls under a recalling firm named Renata Medical, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Renata Medical, Inc. is the lead sponsor of 2 device studies on ClinicalTrials.gov (2 active or recruiting). Most recent:
- NCT06828770: Minima Stent System Post- Approval Study (PAS) (Recruiting, started 2025-05-21)
- NCT05086016: Growth Trial: Study of the Renata Minima Stent (Active not recruiting, started 2021-01-14)
Frequently asked questions
How many FDA 510(k) clearances are listed under Renata Medical, Inc.?
FDA lists 0 510(k) clearances under the applicant name “Renata Medical, Inc.”, plus 1 PMA decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
Which FDA product codes appear under Renata Medical, Inc.?
The most frequent FDA product codes under this applicant name are PNF (Aortic Stent, 1).
Next steps
- See all 0 Renata Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code PNF, Renata Medical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.