PMA
P210037: Prospera Spinal Cord Stimulation (SCS) System, Resilience Percutaneous Lead, HomeStream Remote Management
FDA PMA · Stimulator, spinal-cord, totally implanted for pain relief · Biotronik Nro, Inc.
Key facts
| PMA number | P210037 |
|---|---|
| Trade name | Prospera Spinal Cord Stimulation (SCS) System, Resilience Percutaneous Lead, HomeStream Remote Management |
| Generic name | Stimulator, spinal-cord, totally implanted for pain relief |
| Applicant | Biotronik Nro, Inc. |
| Owner/operator | Biotronik NRO, INC. |
| Product code | LGW |
| Approval date | Mar 31, 2023 |
| Docket number | 23M-1260 |
| Notice date | Apr 5, 2023 |
| Establishment registration | 3027063190 |
| FEI number | 3027063190 |
At a glance
- 10–99 Supplements
- Jun 5, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: