Proclaim Family of Implantable Pulse Generators; St.Jude Medical External Pulse Generator, Clinical Programmer and Patie

FDA premarket approval P010032/S125 · decided 2017-07-21

Approval details

PMA number

P010032

Supplement

S125

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

Proclaim Family of Implantable Pulse Generators; St.Jude Medical External Pulse Generator, Clinical Programmer and Patie

Generic name

Stimulator, spinal-cord, totally implanted for pain relief

Applicant

ABBOTT MEDICAL

Date received

2016-10-24

Decision date

2017-07-21

Days to decision

270 days

Decision code

APPR

Product code

LGW

Advisory committee

Neurology

Expedited review

No

Location

Plano, TX

Statement

Approval for 1) Addition of a Proclaim IPG device models 3661 and 3663, each with a header that is compatible with Medtronic (MDT) leads; 2) Sustaining enhancements to the firmware (FW 1.1 – new version of firmware; 3) Enabling the Burst stimulation feature (marketed as BurstDR stimulation) for Proclaim IPGs with MDT headers and 4) Inclusion of the Lead & Extension Insertion Tool (LEIT).

510(k) clearances by this applicant