NextGen DRG Lead Kit and Accessories

FDA premarket approval P150004/S044 · decided 2021-06-22

Approval details

PMA number

P150004

Supplement

S044

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

NextGen DRG Lead Kit and Accessories

Generic name

Dorsal root ganglion stimulator for pain relief

Applicant

ABBOTT MEDICAL

Date received

2020-12-28

Decision date

2021-06-22

Days to decision

176 days

Decision code

APPR

Product code

PMP

Advisory committee

Neurology

Expedited review

No

Location

Plano, TX

Statement

Approval for design changes to the delivery sheath and tunneling tool, including a new material and locking mechanism for the delivery sheath and a new handle and tip design for the tunneling tool, changes to the packaging configurations of the lead kit and accessories kit, and minor labeling changes to reflect the design and packaging changes. This supplement also requested approval for the addition of Microlumen, Inc. as the new supplier of the delivery sheath, Spectra Medical Inc. as the new

510(k) clearances by this applicant