FDA.reportPublic FDA data

PMA P010032S174

Device
Spinal Cord Stimulation (SCS) System
Applicant
ABBOTT MEDICAL
PMA number
P010032
Supplement
S174
Product code
LGW
Decision date
2021-04-23
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement
Addition of an alternate second tier supplier of a MLCC capacitor component used in the manufacture of Orion family implantable pulse generator (IPG) devices.

Current openFDA PMA Record#

Device
Spinal Cord Stimulation (SCS) System
Applicant
ABBOTT MEDICAL
PMA number
P010032
Supplement
S174
Product code
LGW
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
Decision date
2021-04-23
Decision code
OK30
Date received
2021-03-25
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Addition of an alternate second tier supplier of a MLCC capacitor component used in the manufacture of Orion family implantable pulse generator (IPG) devices.