PMA P010032S193

Device: Lamitrode Tripole 16 Lead 60cm Length (Model 3219), TriCentrus 16 Lead 60cm Length (Model 3292), Octrode Lead 90cm Lengt
Applicant: ABBOTT MEDICAL
Product code: LGW
Decision date: 2023-05-05
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement: Approval for the addition of Magnetic Resonance (MR) Conditional labeling to the Tripole (Model 3219), TriCentrus (Model 3292), and Octrode (Model 3189) leads when used with the Eterna Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG), and an expansion of the MR scan conditions available for use with the Penta (Model 3228) lead.

Current openFDA PMA Record#

Device: Lamitrode Tripole 16 Lead 60cm Length (Model 3219), TriCentrus 16 Lead 60cm Length (Model 3292), Octrode Lead 90cm Lengt
Applicant: ABBOTT MEDICAL
PMA number: P010032
Supplement: S193
Product code: LGW
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Decision date: 2023-05-05
Decision code: APPR
Date received: 2022-09-29
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for the addition of Magnetic Resonance (MR) Conditional labeling to the Tripole (Model 3219), TriCentrus (Model 3292), and Octrode (Model 3189) leads when used with the Eterna Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG), and an expansion of the MR scan conditions available for use with the Penta (Model 3228) lead.