DBS System - Lead and Extension

FDA premarket approval P140009/S084 · decided 2024-02-21

Approval details

PMA number

P140009

Supplement

S084

Supplement type

135 Review Track For 30-Day Notice

Supplement reason

Process Change - Manufacturer/Sterilizer/Packager/Supplier

Trade name

DBS System - Lead and Extension

Generic name

Stimulator, electrical, implanted, for parkinsonian tremor

Applicant

ABBOTT MEDICAL

Date received

2023-06-23

Decision date

2024-02-21

Days to decision

243 days

Decision code

APPR

Product code

MHY

Advisory committee

Neurology

Expedited review

No

Location

Plano, TX

Statement

The firm requested approval to qualify a new manufacturing site and process improvements for an existing supplier of materials used in the manufacture of DBS Leads and Extensions and to utilize a new supplier for components used in the manufacture of the DBS Extensions. Based upon the information submitted, the PMA supplement is approved.

510(k) clearances by this applicant