PMA P150004S046

Device: Dorsal Root Ganglion (DRG) System
Applicant: ABBOTT MEDICAL
PMA number: P150004
Supplement: S046
Product code: PMP
Decision date: 2021-04-23
Generic name: Dorsal root ganglion stimulator for pain relief
Approval order statement: Addition of an alternate second tier supplier of a MLCC capacitor component used in the manufacture of Orion family implantable pulse generator (IPG) devices.

Current openFDA PMA Record#

Device: Dorsal Root Ganglion (DRG) System
Applicant: ABBOTT MEDICAL
PMA number: P150004
Supplement: S046
Product code: PMP
Generic name: Dorsal root ganglion stimulator for pain relief
Decision date: 2021-04-23
Decision code: OK30
Date received: 2021-03-25
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Addition of an alternate second tier supplier of a MLCC capacitor component used in the manufacture of Orion family implantable pulse generator (IPG) devices.