PMA P010032S190
- Device
- Spinal Cord Stimulation (SCS)
- Applicant
- ABBOTT MEDICAL
- PMA number
- P010032
- Supplement
- S190
- Product code
- LGW
- Decision date
- 2022-09-09
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Approval order statement
- Add second tier suppliers of the electrolyte and binder used to build the rechargeable batteries for the implantable pulse generators.
Current openFDA PMA Record#
- Device
- Spinal Cord Stimulation (SCS)
- Applicant
- ABBOTT MEDICAL
- PMA number
- P010032
- Supplement
- S190
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2022-09-09
- Decision code
- OK30
- Date received
- 2022-08-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add second tier suppliers of the electrolyte and binder used to build the rechargeable batteries for the implantable pulse generators.