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PMA P010032S173

Device
Spinal Cord Stimulation (SCS) System
Applicant
ABBOTT MEDICAL
Product code
LGW
Decision date
2021-07-02
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement
Approval for a cleaning process change that replaces the Trichloroethylene (TCE) cleaning agent, used in the first ultrasonic cleaning step to clean Spinal Cord Stimulation (SCS) and Dorsal Root Ganglion (DRG) needles, with CleanSafe-501ESF (CS-501ESF).

Current openFDA PMA Record#

Device
Spinal Cord Stimulation (SCS) System
Applicant
ABBOTT MEDICAL
PMA number
P010032
Supplement
S173
Product code
LGW
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
Decision date
2021-07-02
Decision code
APPR
Date received
2021-03-10
Supplement type
135 Review Track For 30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval for a cleaning process change that replaces the Trichloroethylene (TCE) cleaning agent, used in the first ultrasonic cleaning step to clean Spinal Cord Stimulation (SCS) and Dorsal Root Ganglion (DRG) needles, with CleanSafe-501ESF (CS-501ESF).