PMA P150004S049

Device: Dorsal Root Ganglion (DRG) Implantable Pulse Generator (IPG)
Applicant: ABBOTT MEDICAL
Product code: PMP
Decision date: 2021-09-27
Generic name: Dorsal root ganglion stimulator for pain relief
Approval order statement: Approval for 1) Adding an existing Abbott qualified supplier for diode components for 3 types of diodes. 2) Replacing tantalum decoupling capacitors with ceramic capacitors sourced from an existing Abbott qualified supplier; and 3) Reducing the number of tantalum output capacitors on the EPPIC charge pump.

Current openFDA PMA Record#

Device: Dorsal Root Ganglion (DRG) Implantable Pulse Generator (IPG)
Applicant: ABBOTT MEDICAL
PMA number: P150004
Supplement: S049
Product code: PMP
Generic name: Dorsal root ganglion stimulator for pain relief
Decision date: 2021-09-27
Decision code: APPR
Date received: 2021-06-29
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for 1) Adding an existing Abbott qualified supplier for diode components for 3 types of diodes. 2) Replacing tantalum decoupling capacitors with ceramic capacitors sourced from an existing Abbott qualified supplier; and 3) Reducing the number of tantalum output capacitors on the EPPIC charge pump.