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Device | IMPLANTABLE MULTI-PROGRAMMABLE QUADRIPOLAR DEEP BRAIN STIMULATION SYSTEM |
Generic Name | Stimulator, electrical, implanted, for parkinsonian tremor |
Applicant | MEDTRONIC Inc. 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432-3576 |
PMA Number | P960009 |
Supplement Number | S169 |
Date Received | 03/18/2013 |
Decision Date | 06/22/2015 |
Product Code |
MHY |
Advisory Committee |
Neurology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - PAS |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order 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 THAN ONE LEAD ON THE SAME SIDE OF THE BRAIN IS UNKNOWN. |