PMA P010032S189

Device: Prodigy, Proclaim, and Proclaim XR Spinal Cord Stimulation (SCS) Systems
Applicant: ABBOTT MEDICAL
Product code: LGW
Decision date: 2023-01-24
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement: Approval for expanding the indications to include diabetic peripheral neuropathy (DPN) of the lower extremities for the tonic stimulation mode.

Current openFDA PMA Record#

Device: Prodigy, Proclaim, and Proclaim XR Spinal Cord Stimulation (SCS) Systems
Applicant: ABBOTT MEDICAL
PMA number: P010032
Supplement: S189
Product code: LGW
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Decision date: 2023-01-24
Decision code: APPR
Date received: 2022-07-15
Supplement type: Panel Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for expanding the indications to include diabetic peripheral neuropathy (DPN) of the lower extremities for the tonic stimulation mode.