PMA P010032S166

Device: Proclaim SCS Neurostimulation System
Applicant: ABBOTT MEDICAL
Product code: LGW
Decision date: 2021-01-19
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement: Approval for addition of BurstDR programs with multiple stimsets for Proclaim SCS System, programming enhancements for SCS therapy, cybersecurity enhancements and other minor enhancements for improvement. Approval for cybersecurity enhancements and other minor enhancements for improvement.

Current openFDA PMA Record#

Device: Proclaim SCS Neurostimulation System
Applicant: ABBOTT MEDICAL
PMA number: P010032
Supplement: S166
Product code: LGW
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Decision date: 2021-01-19
Decision code: APPR
Date received: 2020-07-14
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for addition of BurstDR programs with multiple stimsets for Proclaim SCS System, programming enhancements for SCS therapy, cybersecurity enhancements and other minor enhancements for improvement. Approval for cybersecurity enhancements and other minor enhancements for improvement.