PMA P150004S078

Device: Dorsal Root Ganglion (DRG) Implantable Pulse Generator (IPG)
Applicant: ABBOTT MEDICAL
PMA number: P150004
Supplement: S078
Product code: PMP
Decision date: 2024-10-24
Classification: Neurology
Generic name: Dorsal root ganglion stimulator for pain relief
Approval order statement: approval for an alternate supplier for the cable wire utilized in the manufacture of the Multi-Lead Trial Cable and dorsal root ganglion (DRG) Extension Cable

Current openFDA PMA Record#

Device: Dorsal Root Ganglion (DRG) Implantable Pulse Generator (IPG)
Applicant: ABBOTT MEDICAL
PMA number: P150004
Supplement: S078
Product code: PMP
Generic name: Dorsal root ganglion stimulator for pain relief
Decision date: 2024-10-24
Decision code: OK30
Date received: 2024-09-27
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval for an alternate supplier for the cable wire utilized in the manufacture of the Multi-Lead Trial Cable and dorsal root ganglion (DRG) Extension Cable