Spinal Cord Stimulation (SCS)

FDA premarket approval P010032/S172 · decided 2021-07-26

Approval details

PMA number

P010032

Supplement

S172

Supplement type

Real-Time Process

Supplement reason

Change Design/Components/Specifications/Material

Trade name

Spinal Cord Stimulation (SCS)

Generic name

Stimulator, spinal-cord, totally implanted for pain relief

Applicant

ABBOTT MEDICAL

Date received

2021-02-12

Decision date

2021-07-26

Days to decision

164 days

Decision code

APPR

Product code

LGW

Advisory committee

Neurology

Expedited review

No

Location

Plano, TX

Statement

Approval for the replacement of the supplier for the Thermal Cutoff (TCO) component used in the lithium ion (Li-Ion) Rechargeable Battery Pack used to recharge Implanted Pulse Generator (IPG), and for a design change to the TCO component of the Battery Pack. The design change includes the addition of a bottom metal strap to the TCO component, different dimensions of the Battery Pack due to the thicker new TCO component, an increased current allowance from 2 Amps to 7 Amps, lower voltage cutoff f

510(k) clearances by this applicant