PMA P010032

Device
Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG)
Applicant
ABBOTT MEDICAL
PMA number
P010032
Supplement
S194
Product code
LGW
Decision date
2026-07-26
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement
to utilize alternate drop-in diode components in the Printed Circuit Board Assemblies of its Implantable Pulse Generators

Current openFDA PMA Record#

Device
Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG)
Applicant
ABBOTT MEDICAL
PMA number
P010032
Supplement
S259
Product code
LGW
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
Decision date
2026-07-26
Decision code
OK30
Date received
2026-06-26
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
to utilize alternate drop-in diode components in the Printed Circuit Board Assemblies of its Implantable Pulse Generators