Prospera Spinal Cord Stimulation (SCS) System, Resilience Percutaneous Lead, HomeStream Remote Management
FDA premarket approval P210037/S011 · decided 2025-06-25
Approval details
- PMA number
- P210037
- Supplement
- S011
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- 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.
- Date received
- 2025-04-04
- Decision date
- 2025-06-25
- Days to decision
- 82 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Lake Oswego, OR
- Statement
- approval for changes made to the Prospera SCS System embedded software (implant software [ISW]) and Neuro Service Center (NSC). Specifically, the Prospera SCS System embedded software (ISW) was updated to version 1.0.3, which included changes to the lead impedance measurements algorithm to provide more information during intraoperative testing and improve the accuracy of calculation of resistive measurements. The NSC was updated to version 1.6.3, which included changes to allow magnetic resonanc
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.