DRG Lead Extension Kit

FDA premarket approval P150004/S015 · decided 2017-10-13

Approval details

PMA number

P150004

Supplement

S015

Supplement type

30-Day Notice

Supplement reason

Process Change - Manufacturer/Sterilizer/Packager/Supplier

Trade name

DRG Lead Extension Kit

Generic name

Dorsal root ganglion stimulator for pain relief

Applicant

ABBOTT MEDICAL

Date received

2017-09-13

Decision date

2017-10-13

Days to decision

30 days

Decision code

OK30

Product code

PMP

Advisory committee

Neurology

Expedited review

No

Location

Plano, TX

Statement

Changes to the dorsal root ganglion (DRG) lead extension manufacturing process at the St. Jude Medical (SJM) Plano, Texas facility. Specifically, it requested updates to the DRG lead extension socket assembly and header molding processes. These changes only apply to the DRG lead extension header component assembly and molding process.

510(k) clearances by this applicant