Spinal Cord Stimulation (SCS) System

FDA premarket approval P010032/S192 · decided 2023-04-28

Approval details

PMA number

P010032

Supplement

S192

Supplement type

135 Review Track For 30-Day Notice

Supplement reason

Process Change - Manufacturer/Sterilizer/Packager/Supplier

Trade name

Spinal Cord Stimulation (SCS) System

Generic name

Stimulator, spinal-cord, totally implanted for pain relief

Applicant

ABBOTT MEDICAL

Date received

2022-09-15

Decision date

2023-04-28

Days to decision

225 days

Decision code

APPR

Product code

LGW

Advisory committee

Neurology

Expedited review

No

Location

Plano, TX

Statement

Approval for a change in cleanroom classification from ISO 8 to ISO 9 in the Controlled Access Environment (CAE) room in Abbott's Arecibo, Puerto Rico (PR) manufacturing site and a diameter nozzle change for the mold release spray. The change is being made to align with the cleanroom classification for the same manufacturing operations and processes in Plano, TX. Abbott is also seeking this higher classification to accommodate for the change in the larger diameter mold release spray.

510(k) clearances by this applicant