FDA.reportPublic FDA data

PMA P140009S076

Device
Infinity Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG)
Applicant
ABBOTT MEDICAL
PMA number
P140009
Supplement
S076
Product code
MHY
Decision date
2022-03-24
Generic name
Stimulator, electrical, implanted, for parkinsonian tremor
Approval order statement
Update to the Post-Header Test System Non-Product Software used during assembly of Orion family (Proclaim SCS, Infinity DBS, Proclaim DRG) Implantable Pulse Generators (IPGs).

Current openFDA PMA Record#

Device
Infinity Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG)
Applicant
ABBOTT MEDICAL
PMA number
P140009
Supplement
S076
Product code
MHY
Generic name
Stimulator, electrical, implanted, for parkinsonian tremor
Decision date
2022-03-24
Decision code
OK30
Date received
2022-02-22
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Update to the Post-Header Test System Non-Product Software used during assembly of Orion family (Proclaim SCS, Infinity DBS, Proclaim DRG) Implantable Pulse Generators (IPGs).