PMA P010032S183

Device: Proclaim SCS IPG
Applicant: ABBOTT MEDICAL
PMA number: P010032
Supplement: S183
Product code: LGW
Decision date: 2021-11-16
Generic name: Stimulator, spinal-cord, totally implanted 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 SCS IPG
Applicant: ABBOTT MEDICAL
PMA number: P010032
Supplement: S183
Product code: LGW
Generic name: Stimulator, spinal-cord, totally implanted 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.