PMA P150004S085
- Device
- Proclaim Dorsal Root Ganglion (DRG) Neurostimulator System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P150004
- Supplement
- S085
- Product code
- PMP
- Decision date
- 2026-01-13
- Classification
- Neurology
- Generic name
- Dorsal root ganglion stimulator for pain relief
- Approval order statement
- Approval for expanded MR Conditional labeling to include prone positioning for the Proclaim DRG System.
Current openFDA PMA Record#
- Device
- Proclaim Dorsal Root Ganglion (DRG) Neurostimulator System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P150004
- Supplement
- S085
- Product code
- PMP
- Generic name
- Dorsal root ganglion stimulator for pain relief
- Decision date
- 2026-01-13
- Decision code
- APPR
- Date received
- 2025-06-04
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for expanded MR Conditional labeling to include prone positioning for the Proclaim DRG System.