PMA P010032S246
- Device
- Proclaim™ Spinal Cord Stimulation (SCS) System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P010032
- Supplement
- S246
- Product code
- LGW
- Decision date
- 2025-12-23
- Classification
- Neurology
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Approval order statement
- to implement quality control testing changes for the neuromodulation devices manufactured in Arecibo, Puerto Rico
Current openFDA PMA Record#
- Device
- Proclaim™ Spinal Cord Stimulation (SCS) System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P010032
- Supplement
- S246
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2025-12-23
- Decision code
- OK30
- Date received
- 2025-11-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to implement quality control testing changes for the neuromodulation devices manufactured in Arecibo, Puerto Rico