FDA.reportPublic FDA data

PMA P140009S063

Device
Infinity Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG)
Applicant
ABBOTT MEDICAL
PMA number
P140009
Supplement
S063
Product code
MHY
Decision date
2020-08-18
Generic name
Stimulator, electrical, implanted, for parkinsonian tremor
Approval order statement
Approval for a minor design change to remove a microelectromechanical systems (MEMS) sensor, which is an accelerometer component on the IPG’s printed circuit board. This MEMS sensor was intended to detect and collect data on patient activity levels for research and development purposes only; it is not related to product performance.

Current openFDA PMA Record#

Device
Infinity Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG)
Applicant
ABBOTT MEDICAL
PMA number
P140009
Supplement
S063
Product code
MHY
Generic name
Stimulator, electrical, implanted, for parkinsonian tremor
Decision date
2020-08-18
Decision code
APPR
Date received
2020-07-27
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for a minor design change to remove a microelectromechanical systems (MEMS) sensor, which is an accelerometer component on the IPG’s printed circuit board. This MEMS sensor was intended to detect and collect data on patient activity levels for research and development purposes only; it is not related to product performance.