FDA.reportPublic FDA data

PMA P010032S170

Device
Genesis Neurostimulation System
Applicant
ABBOTT MEDICAL
PMA number
P010032
Supplement
S170
Product code
LGW
Decision date
2021-02-03
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement
Use of an alternate component supplier Deringer-Ney Inc (DNI) for the electrodes used in Penta Lamitrode Leads, Models 3227, 3228, & 3229. DNI, will stamp the electrodes instead of machine the electrodes to tighter tolerance values.

Current openFDA PMA Record#

Device
Genesis Neurostimulation System
Applicant
ABBOTT MEDICAL
PMA number
P010032
Supplement
S170
Product code
LGW
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
Decision date
2021-02-03
Decision code
OK30
Date received
2020-12-17
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Use of an alternate component supplier Deringer-Ney Inc (DNI) for the electrodes used in Penta Lamitrode Leads, Models 3227, 3228, & 3229. DNI, will stamp the electrodes instead of machine the electrodes to tighter tolerance values.