- Device
- Spinal Cord Stimulation (SCS) System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P010032
- Supplement
- S169
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2021-02-24
- Decision code
- APPR
- Date received
- 2020-10-28
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval to change the grade in raw materials used in the formulation of the Green Solvent, used for in-process cleaning of leads and pins.