Proclaim SCS Neurostimulation System

FDA premarket approval P010032/S176 · decided 2021-11-17

Approval details

PMA number

P010032

Supplement

S176

Supplement type

Normal 180 Day Track

Supplement reason

Labeling Change - Indications/instructions/shelf life/tradename

Trade name

Proclaim SCS Neurostimulation System

Generic name

Stimulator, spinal-cord, totally implanted for pain relief

Applicant

ABBOTT MEDICAL

Date received

2021-06-01

Decision date

2021-11-17

Days to decision

169 days

Decision code

APPR

Product code

LGW

Advisory committee

Neurology

Expedited review

No

Location

Plano, TX

Statement

Approval for expanded magnetic resonance (MR) Conditional labeling for the Octrode 60cm Lead when implanted with the Proclaim XR IPGs (Models 3660 and 3662) and their associated accessories, including the port plug and lead anchors. This supplement requested expansion of the conditions of use within the MRI labeling to increase radiofrequency (RF) power limit from whole body SAR <=0.8 W/kg to normal operating mode (NOM) for scans using integrated body RF transmit coil with any receive coil, and

510(k) clearances by this applicant