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

FDA premarket approval P010032/S194 · decided 2022-10-28

Approval details

PMA number

P010032

Supplement

S194

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

2022-09-29

Decision date

2022-10-28

Days to decision

29 days

Decision code

OK30

Product code

LGW

Advisory committee

Neurology

Expedited review

No

Location

Plano, TX

Statement

Implement two manufacturing changes used in the production of contact assemblies in supplier Bal Seal Engineering, Inc.’s production of contact assemblies, i.e., 1) to qualify alternate welding equipment used to process the spring component of contact assemblies; and 2) to implement visual automated optical inspection for performing the 100% inspection of the spring component's inner diameter.

510(k) clearances by this applicant