PMA P150004S088
- Device
- Proclaim™ DRG System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P150004
- Supplement
- S088
- Product code
- PMP
- Decision date
- 2025-09-26
- Classification
- Neurology
- Generic name
- Dorsal root ganglion stimulator for pain relief
- Approval order statement
- approval for an alternate second tier supplier of carbon fiber for use in cathode of the battery
Current openFDA PMA Record#
- Device
- Proclaim™ DRG System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P150004
- Supplement
- S088
- Product code
- PMP
- Generic name
- Dorsal root ganglion stimulator for pain relief
- Decision date
- 2025-09-26
- Decision code
- APPR
- Date received
- 2025-06-30
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval for an alternate second tier supplier of carbon fiber for use in cathode of the battery