- Device
- Proclaim™ Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG)
- Applicant
- ABBOTT MEDICAL
- PMA number
- P010032
- Supplement
- S248
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2026-03-13
- Decision code
- OK30
- Date received
- 2026-02-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval to consolidate manufacturing activities from two manufacturing facilities into a single manufacturing facility and to utilize new equipment at the consolidated manufacturing facility