Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG)

FDA premarket approval P010032/S220 · decided 2024-07-26

Approval details

PMA number

P010032

Supplement

S220

Supplement type

30-Day Notice

Supplement reason

Process Change - Manufacturer/Sterilizer/Packager/Supplier

Trade name

Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG)

Generic name

Stimulator, spinal-cord, totally implanted for pain relief

Applicant

ABBOTT MEDICAL

Date received

2024-07-01

Decision date

2024-07-26

Days to decision

25 days

Decision code

OK30

Product code

LGW

Advisory committee

Neurology

Expedited review

No

Location

Plano, TX

Statement

a manufacturing change in supplier Bal Seal Engineering, Inc.'s production of contact assemblies, manufactured for Abbott's IPGs final finished devices. Specifically, during the “weld” step, Bal Seal will process the spring components using either Point-Welded (with current resistance weld process) or Butt-Welded (with proposed laser weld process)

510(k) clearances by this applicant