PMA P010032S180

Device
Spinal Cord Stimulation (SCS) System
Applicant
ABBOTT MEDICAL
Product code
LGW
Decision date
2021-12-30
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement
Approval to add Midwest Sterilization Corporation located at 1204 Lenco Ave. Jackson, Mo 63755 as an alternate ethylene oxide (EO) sterility facility.

Current openFDA PMA Record#

Device
Spinal Cord Stimulation (SCS) System
Applicant
ABBOTT MEDICAL
PMA number
P010032
Supplement
S180
Product code
LGW
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
Decision date
2021-12-30
Decision code
APPR
Date received
2021-09-27
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval to add Midwest Sterilization Corporation located at 1204 Lenco Ave. Jackson, Mo 63755 as an alternate ethylene oxide (EO) sterility facility.