GENESIS PROGRAMMER, EON PATIENT PROGRAMMER, PROTEGE PROGRAMMER, PATIENT PROGRAMMER (MRI)

FDA premarket approval P010032/S098 · decided 2015-11-02

Approval details

PMA number

P010032

Supplement

S098

Supplement type

Real-Time Process

Supplement reason

Change Design/Components/Specifications/Material

Trade name

GENESIS PROGRAMMER, EON PATIENT PROGRAMMER, PROTEGE PROGRAMMER, PATIENT PROGRAMMER (MRI)

Generic name

Stimulator, spinal-cord, totally implanted for pain relief

Applicant

ABBOTT MEDICAL

Date received

2015-08-04

Decision date

2015-11-02

Days to decision

90 days

Decision code

APPR

Product code

LGW

Advisory committee

Neurology

Expedited review

No

Location

Plano, TX

Statement

APPROVAL FOR 1) EXPANDED MRI CONDITIONS FOR MEDTRONIC DBS SYSTEMS; 2) UPDATES TO THE MODEL 37651 PATIENT RECHARGER SYSTEM;3) CLARIFICATIONS TO THE GUIDELINES FOR CONDUCTING CT SCANS ON DBS PATIENTS; 4) ADDITION OF SYMBOLS TO STERILE AND SHELF-BOX PACKAGE LABELS FOR SPECIFIED MODELS; AND (5) UPDATES TO PACKAGE CONFIGURATIONS FOR SPECIFIED MODELS.

510(k) clearances by this applicant