- Device
- Prospera Spinal Cord Stimulation (SCS) System, Resilience Percutaneous Lead, HomeStream Remote Management
- Applicant
- Biotronik Nro, Inc.
- PMA number
- P210037
- Supplement
- S015
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2026-04-24
- Decision code
- OK30
- Date received
- 2026-03-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to remove two redundant incoming inspections (Bend Test and X-Ray Test) conducted on the Resilience percutaneous leads