FDA.reportPublic FDA data

PMA P140009S071

Device
Infinity Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG)
Applicant
ABBOTT MEDICAL
Product code
MHY
Decision date
2021-09-27
Generic name
Stimulator, electrical, implanted, for parkinsonian tremor
Approval order statement
Approval for 1) Adding an existing Abbott qualified supplier for diode components for 3 types of diodes. 2) Replacing tantalum decoupling capacitors with ceramic capacitors sourced from an existing Abbott qualified supplier; and 3) Reducing the number of tantalum output capacitors on the EPPIC charge pump.

Current openFDA PMA Record#

Device
Infinity Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG)
Applicant
ABBOTT MEDICAL
PMA number
P140009
Supplement
S071
Product code
MHY
Generic name
Stimulator, electrical, implanted, for parkinsonian tremor
Decision date
2021-09-27
Decision code
APPR
Date received
2021-06-29
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for 1) Adding an existing Abbott qualified supplier for diode components for 3 types of diodes. 2) Replacing tantalum decoupling capacitors with ceramic capacitors sourced from an existing Abbott qualified supplier; and 3) Reducing the number of tantalum output capacitors on the EPPIC charge pump.