Saluda Medical Pty, Ltd.: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Saluda Medical Pty, Ltd.”, 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 |
|---|---|---|---|
| LGW | Stimulator, Spinal-Cord, Totally Implanted For Pain Relief | 1 | 0 |
Review panels
- Neurology (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P190002 | PMA | Saluda Medical Evoke SCS System | 2022-02-28 |
Recalls
openFDA lists no recalls under a recalling firm named Saluda Medical Pty, Ltd..
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 Saluda Medical Pty, Ltd. is the lead sponsor of 7 device studies on ClinicalTrials.gov (3 active or recruiting). Most recent:
- NCT06229470: Clinical Utility of Neurophysiological Measurements of ECAP-controlled Closed-loop SCS to Guide Treatment of Chronic Pain (Active not recruiting, started 2024-03-08)
- NCT06057480: APM in the Evoke SCS System to Program Patients With Chronic Pain of the Trunk and/or Limbs (Completed, started 2023-09-26)
- NCT05272137: Evoke Data Collection Study Germany (Completed, started 2022-02-04)
- NCT04662905: Novel Treatment Delivery of ECAP-controlled Closed-loop SCS for Chronic Pain (Recruiting, started 2020-12-15)
- NCT04319887: ECAP-controlled, Closed-loop Stimulation to Treat Chronic Trunk and/or Limb Pain (ECAP) (Completed, started 2020-10-29)
Frequently asked questions
How many FDA 510(k) clearances are listed under Saluda Medical Pty, Ltd.?
FDA lists 0 510(k) clearances under the applicant name “Saluda Medical Pty, Ltd.”, 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 Saluda Medical Pty, Ltd.?
The most frequent FDA product codes under this applicant name are LGW (Stimulator, Spinal-Cord, Totally Implanted For Pain Relief, 1).
Next steps
- See all 0 Saluda Medical Pty, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code LGW, Saluda Medical Pty, Ltd.'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.