PMA P010032S147
- Device
- SCS EPG Header
- Applicant
- ABBOTT MEDICAL
- PMA number
- P010032
- Supplement
- S147
- Product code
- LGW
- Decision date
- 2019-03-26
- Classification
- Stimulator, Spinal-cord, Totally Implanted For Pain Relief
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Approval order statement
- Approval for design changes including increasing the thickness of the polyimide substrate and decreasing the thickness of the polyimide coverfilm on the Flex Printed Circuit Board (PCB) on the Spinal Cord Stimulation External Pulse Generator (SCS EPG) header, model 3032.
Current openFDA PMA Record#
- Device
- SCS EPG Header
- Applicant
- ABBOTT MEDICAL
- PMA number
- P010032
- Supplement
- S147
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2019-03-26
- Decision code
- APPR
- Date received
- 2018-12-26
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for design changes including increasing the thickness of the polyimide substrate and decreasing the thickness of the polyimide coverfilm on the Flex Printed Circuit Board (PCB) on the Spinal Cord Stimulation External Pulse Generator (SCS EPG) header, model 3032.