PMA P010032S137

Device
SCS Accessory and A127 Extension Kits
Applicant
ABBOTT MEDICAL
PMA number
P010032
Supplement
S137
Product code
LGW
Decision date
2018-02-13
Classification
Stimulator, Spinal-cord, Totally Implanted For Pain Relief
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement
Approval for removal of the Trial cable (also called ETE) from the SCS Accessory Kit and A127 Lead Extension Kit.

Current openFDA PMA Record#

Device
SCS Accessory and A127 Extension Kits
Applicant
ABBOTT MEDICAL
PMA number
P010032
Supplement
S137
Product code
LGW
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
Decision date
2018-02-13
Decision code
APPR
Date received
2017-11-15
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for removal of the Trial cable (also called ETE) from the SCS Accessory Kit and A127 Lead Extension Kit.