FDA.reportPublic FDA data

PMA P010032S181

Device
Genesis Neurostimulation System
Applicant
ABBOTT MEDICAL
PMA number
P010032
Supplement
S181
Product code
LGW
Decision date
2021-11-03
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement
Consolidate the Electrical testing at the cleaning step and QC inspection step of the manufacturing process and for the consolidated step to be performed after the Weld tip/Leak test step using automated CAMI lead test system in the Abbott Medical Puerto Rico, LLC manufacturing site.

Current openFDA PMA Record#

Device
Genesis Neurostimulation System
Applicant
ABBOTT MEDICAL
PMA number
P010032
Supplement
S181
Product code
LGW
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
Decision date
2021-11-03
Decision code
OK30
Date received
2021-10-01
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Consolidate the Electrical testing at the cleaning step and QC inspection step of the manufacturing process and for the consolidated step to be performed after the Weld tip/Leak test step using automated CAMI lead test system in the Abbott Medical Puerto Rico, LLC manufacturing site.