DRG System - Leads and Extensions

FDA premarket approval P150004/S065 · decided 2024-01-22

Approval details

PMA number

P150004

Supplement

S065

Supplement type

135 Review Track For 30-Day Notice

Supplement reason

Process Change - Manufacturer/Sterilizer/Packager/Supplier

Trade name

DRG System - Leads and Extensions

Generic name

Dorsal root ganglion stimulator for pain relief

Applicant

ABBOTT MEDICAL

Date received

2023-08-08

Decision date

2024-01-22

Days to decision

167 days

Decision code

APPR

Product code

PMP

Advisory committee

Neurology

Expedited review

No

Location

Plano, TX

Statement

for the qualification of alternate resin supplier manufacturing site, supplier process changes associated with the alternate resin manufacturing site, and the utilization of an alternate supplier for raw material used to manufacture the resin.

510(k) clearances by this applicant