Lamitrode Tripole 16 Lead 60cm Length (Model 3219), TriCentrus 16 Lead 60cm Length (Model 3292), Octrode Lead 90cm Lengt

FDA premarket approval P010032/S193 · decided 2023-05-05

Approval details

PMA number

P010032

Supplement

S193

Supplement type

Normal 180 Day Track

Supplement reason

Labeling Change - Indications/instructions/shelf life/tradename

Trade name

Lamitrode Tripole 16 Lead 60cm Length (Model 3219), TriCentrus 16 Lead 60cm Length (Model 3292), Octrode Lead 90cm Lengt

Generic name

Stimulator, spinal-cord, totally implanted for pain relief

Applicant

ABBOTT MEDICAL

Date received

2022-09-29

Decision date

2023-05-05

Days to decision

218 days

Decision code

APPR

Product code

LGW

Advisory committee

Neurology

Expedited review

No

Location

Plano, TX

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.

510(k) clearances by this applicant