- Device
- Eterna SCS and Proclaim SCS Systems
- Applicant
- ABBOTT MEDICAL
- PMA number
- P010032
- Supplement
- S237
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2026-01-13
- Decision code
- APPR
- Date received
- 2025-05-09
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- approval for labeling changes to expand the ‘Magnetic Resonance (MR) Conditional’ labeling to include prone positioning for the Eterna and Proclaim SCS Systems, as well as update the radiofrequency (RF) heating conditions and lead tip implant location for supine positioning for the Proclaim SCS System to ensure consistency in the labeling between the Eterna and Proclaim SCS Systems