PMA P150004S067

Device: Dorsal Root Ganglion Stimulation (DRG) Implantable Pulse Generators (IPGs), leads, extensions, and accessories
Applicant: ABBOTT MEDICAL
PMA number: P150004
Supplement: S067
Product code: PMP
Decision date: 2023-09-29
Classification: Neurology
Generic name: Dorsal root ganglion stimulator for pain relief
Approval order statement: Improvements to the quality control testing that is performed on finished device software applications to ensure that they continue to operate as intended on new mobile platforms or iOS versions.

Current openFDA PMA Record#

Device: Dorsal Root Ganglion Stimulation (DRG) Implantable Pulse Generators (IPGs), leads, extensions, and accessories
Applicant: ABBOTT MEDICAL
PMA number: P150004
Supplement: S067
Product code: PMP
Generic name: Dorsal root ganglion stimulator for pain relief
Decision date: 2023-09-29
Decision code: OK30
Date received: 2023-09-01
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Improvements to the quality control testing that is performed on finished device software applications to ensure that they continue to operate as intended on new mobile platforms or iOS versions.