Data / Medical devices / United States / Biotronik Nro, Inc.
Biotronik Nro, Inc.: FDA-registered device maker in Lake Oswego, OR, United States, 1 PMA approval
Biotronik Nro, Inc. is registered with the FDA (registration 3027063190) in Lake Oswego, OR, United States. It lists 1 device type. The FDA files 1 PMA approval under its listings, the newest dated March 31, 2023. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3027063190
- Address
- 6024 Jean Road, Lake Oswego, OR, United States, 97035
- Owner or operator
- Biotronik NRO, INC. (10087752)
- Roles
- Repackager or relabeler
- First device listed
- April 4, 2023
- Registered through
- 2027
- Brand names listed
- Embrace One, HomeStream Remote Management, Prospera Spinal Cord Stimulation (SCS) System, Resilience Percutaneous Lead, TrueLock
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Stimulator, Spinal-Cord, Totally Implanted For Pain Relief | LGW | 3 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| March 31, 2023 | P210037 | Prospera Spinal Cord Stimulation (SCS) System, Resilience Percutaneous Lead, HomeStream Remote Management | LGW | 14 | June 5, 2026 | accessdata.fda.gov |
Compare with other makers
Updated June 5, 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.