PMA P150004S054

Device: Proclaim DRG IPG
Applicant: ABBOTT MEDICAL
PMA number: P150004
Supplement: S054
Product code: PMP
Decision date: 2021-11-16
Generic name: Dorsal root ganglion stimulator for pain relief
Approval order statement: Approval to 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: Proclaim DRG IPG
Applicant: ABBOTT MEDICAL
PMA number: P150004
Supplement: S054
Product code: PMP
Generic name: Dorsal root ganglion stimulator for pain relief
Decision date: 2021-11-16
Decision code: APPR
Date received: 2021-10-22
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval to 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.