Proclaim™ Spinal Cord Simulation Implantable Pulse Generator (IPG)

FDA premarket approval P010032/S227 · decided 2025-01-13

Approval details

PMA number

P010032

Supplement

S227

Supplement type

Real-Time Process

Supplement reason

Labeling Change - Indications/instructions/shelf life/tradename

Trade name

Proclaim™ Spinal Cord Simulation Implantable Pulse Generator (IPG)

Generic name

Stimulator, spinal-cord, totally implanted for pain relief

Applicant

ABBOTT MEDICAL

Date received

2024-10-15

Decision date

2025-01-13

Days to decision

90 days

Decision code

APPR

Product code

LGW

Advisory committee

Neurology

Expedited review

No

Location

Plano, TX

Statement

Approval for firmware version 1.3 and OneApp version 4.1, which include an expanded impedance range and updated trim values used for Magnetic Resonance Imaging (MRI) Mode, updated Elective Replacement Indicator requirement for Orion IPG systems, and labeling updates to account for these changes. You are also proposing to add a check for the MR conditional status of the combination of leads and Implanted Pulse Generators before entering MRI Mode, specify spinal cord stimulation therapy type for t

510(k) clearances by this applicant