PMA P150004S070

Device
Dorsal Root Ganglion (DRG) Implantable Pulse Generator (IPG)
Applicant
ABBOTT MEDICAL
PMA number
P150004
Supplement
S070
Product code
PMP
Decision date
2024-04-05
Classification
Neurology
Generic name
Dorsal root ganglion stimulator for pain relief
Approval order statement
revert manufacturing of IPG boards for SCS, DRG and DBS to original C68 component

Current openFDA PMA Record#

Device
Dorsal Root Ganglion (DRG) Implantable Pulse Generator (IPG)
Applicant
ABBOTT MEDICAL
PMA number
P150004
Supplement
S070
Product code
PMP
Generic name
Dorsal root ganglion stimulator for pain relief
Decision date
2024-04-05
Decision code
APPR
Date received
2024-03-07
Supplement type
Special (Immediate Track)
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
revert manufacturing of IPG boards for SCS, DRG and DBS to original C68 component