PMA P150004S074

Device
SlimTip™ Dorsal Root Ganglion (DRG) Trial Lead Kit, 50cm, SlimTip™ Dorsal Root Ganglion (DRG) Trial Lead Kit, 90cm, Slim
Applicant
ABBOTT MEDICAL
PMA number
P150004
Supplement
S074
Product code
PMP
Decision date
2025-03-12
Classification
Neurology
Generic name
Dorsal root ganglion stimulator for pain relief
Approval order statement
This premarket approval application (PMA) 180-day supplement requested approval for design changes to the DRG sheaths used in the DRG Lead Kits and Sheath Accessory Kits

Current openFDA PMA Record#

Device
SlimTip™ Dorsal Root Ganglion (DRG) Trial Lead Kit, 50cm, SlimTip™ Dorsal Root Ganglion (DRG) Trial Lead Kit, 90cm, Slim
Applicant
ABBOTT MEDICAL
PMA number
P150004
Supplement
S074
Product code
PMP
Generic name
Dorsal root ganglion stimulator for pain relief
Decision date
2025-03-12
Decision code
APPR
Date received
2024-04-26
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
This premarket approval application (PMA) 180-day supplement requested approval for design changes to the DRG sheaths used in the DRG Lead Kits and Sheath Accessory Kits