PMA P150004S073

Device
Axium Neurostimulator System
Applicant
ABBOTT MEDICAL
PMA number
P150004
Supplement
S073
Product code
PMP
Decision date
2024-07-24
Classification
Neurology
Generic name
Dorsal root ganglion stimulator for pain relief
Approval order statement
approval for the adoption of Dorsal Root Ganglion (DRG) leads and extensions into the existing Cycle 59 at Midwest Sterilization Corporation

Current openFDA PMA Record#

Device
Axium Neurostimulator System
Applicant
ABBOTT MEDICAL
PMA number
P150004
Supplement
S073
Product code
PMP
Generic name
Dorsal root ganglion stimulator for pain relief
Decision date
2024-07-24
Decision code
APPR
Date received
2024-04-26
Supplement type
Real-Time Process
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
approval for the adoption of Dorsal Root Ganglion (DRG) leads and extensions into the existing Cycle 59 at Midwest Sterilization Corporation