PMA P010032S150

Device: Genesis Neurostimulation System
Applicant: ABBOTT MEDICAL
PMA number: P010032
Supplement: S150
Product code: LGW
Decision date: 2019-07-15
Classification: Stimulator, Spinal-cord, Totally Implanted For Pain Relief
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement: Approval to add Midwest Sterilization Corporation, 1204 Lenco Avenue, Jackson, Missouri, as an alternate ethylene oxide sterilization site for numerous neuromodulation products.

Current openFDA PMA Record#

Device: Genesis Neurostimulation System
Applicant: ABBOTT MEDICAL
PMA number: P010032
Supplement: S150
Product code: LGW
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Decision date: 2019-07-15
Decision code: APPR
Date received: 2019-05-07
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, 1204 Lenco Avenue, Jackson, Missouri, as an alternate ethylene oxide sterilization site for numerous neuromodulation products.