PMA P010032S149

Device: Proclaim family of SCS IPGs
Applicant: ABBOTT MEDICAL
Product code: LGW
Decision date: 2019-09-17
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement: Approval for updating the Clinician Programmer Application and Patient Controller Application to support an expanded allowable impedance range for MR Conditional devices entering MRI Mode, and to amend your labeling and software to change the term Program Mode to Dosage and Cycle to Intermittent.

Current openFDA PMA Record#

Device: Proclaim family of SCS IPGs
Applicant: ABBOTT MEDICAL
PMA number: P010032
Supplement: S149
Product code: LGW
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Decision date: 2019-09-17
Decision code: APPR
Date received: 2019-03-21
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for updating the Clinician Programmer Application and Patient Controller Application to support an expanded allowable impedance range for MR Conditional devices entering MRI Mode, and to amend your labeling and software to change the term Program Mode to Dosage and Cycle to Intermittent.