FDA.reportPublic FDA data

PMA P140009S074

Device
Infinity DBS IPG
Applicant
ABBOTT MEDICAL
PMA number
P140009
Supplement
S074
Product code
MHY
Decision date
2021-11-16
Generic name
Stimulator, electrical, implanted, for parkinsonian tremor
Approval order statement
Approval to 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 DBS IPG
Applicant
ABBOTT MEDICAL
PMA number
P140009
Supplement
S074
Product code
MHY
Generic name
Stimulator, electrical, implanted, for parkinsonian tremor
Decision date
2021-11-16
Decision code
APPR
Date received
2021-10-22
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval to 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.