PMA P140009S138

Device
Deep Brain Stimulation (DBS) IPG
Applicant
ABBOTT MEDICAL
PMA number
P140009
Supplement
S138
Product code
MHY
Decision date
2026-07-26
Classification
Neurology
Generic name
Stimulator, electrical, implanted, for parkinsonian tremor
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
Deep Brain Stimulation (DBS) IPG
Applicant
ABBOTT MEDICAL
PMA number
P140009
Supplement
S138
Product code
MHY
Generic name
Stimulator, electrical, implanted, for parkinsonian tremor
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