IMPLANTABLE MULTI-PROGRAMMABLE QUADRIPOLAR DEEP BRAIN STIMULATION SYSTEM

FDA premarket approval P960009/S169 · decided 2015-06-22

Approval details

PMA number

P960009

Supplement

S169

Supplement type

Normal 180 Day Track No User Fee

Supplement reason

Labeling Change - PAS

Trade name

IMPLANTABLE MULTI-PROGRAMMABLE QUADRIPOLAR DEEP BRAIN STIMULATION SYSTEM

Generic name

Stimulator, electrical, implanted, for parkinsonian tremor

Applicant

Medtronic, Inc.

Date received

2013-03-18

Decision date

2015-06-22

Days to decision

826 days

Decision code

APPR

Product code

MHY

Advisory committee

Neurology

Expedited review

No

Location

Minneapolis, MN

Statement

APPROVAL FOR A LABELING UPDATE THAT MODIFIES YOUR DEEP BRAIN STIMULATION (DBS) THERAPY INFORMATION FOR PRESCRIBER¿S AND THE DBS PATIENT THERAPY GUIDE. THE LABELING UPDATE IS TO MODIFY TWO PRECAUTIONS THAT APPEAR IN EACH MANUAL:1) REMOVE THE PRECAUTION ON POTENTIAL RELEASE OF NEUROTOXIC AND CARCINOGENIC COMPOUNDS FROM POLYURETHANE LEAD MATERIALS; AND2) MODIFY THE PRECAUTION ON LONG-TERM SAFETY OF MULTIPLE LEADS AND REPLACEMENT LEADS TO READ: THE LONG-TERM SAFETY ASSOCIATED WITH IMPLANTING MORE TH

510(k) clearances by this applicant