PMA P010032S156
- Device
- Proclaim family of SCS IPGs
- Applicant
- ABBOTT MEDICAL
- Product code
- LGW
- Decision date
- 2020-06-05
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Approval order statement
- Approval for cybersecurity software updates for the Clinician Programmer (CP) and Patient Controller (PC).
Current openFDA PMA Record#
- Device
- Proclaim family of SCS IPGs
- Applicant
- ABBOTT MEDICAL
- PMA number
- P010032
- Supplement
- S156
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2020-06-05
- Decision code
- APPR
- Date received
- 2019-11-08
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for cybersecurity software updates for the Clinician Programmer (CP) and Patient Controller (PC).