FDA.reportPublic FDA data

PMA P010032S185

Device
Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG)
Applicant
ABBOTT MEDICAL
PMA number
P010032
Supplement
S185
Product code
LGW
Decision date
2022-03-24
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
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
Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG)
Applicant
ABBOTT MEDICAL
PMA number
P010032
Supplement
S185
Product code
LGW
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
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).