- Device
- St. Jude Medical Clinician Programmer Application, St. Jude Medical Patient Controller Application, Proclaim XR 5 Implan
- Applicant
- ABBOTT MEDICAL
- PMA number
- P010032
- Supplement
- S177
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2021-07-15
- Decision code
- APPR
- Date received
- 2021-06-15
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for labeling updates to include additional clarification language related to magnets within consumer goods and electronic devices.