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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceDEEP BRAIN STIMULATION (DBS) EXTENSION KITS
Classification Namestimulator, electrical, implanted, for parkinsonian tremor
Generic Namestimulator, electrical, implanted, for parkinsonian tremor
Applicant
MEDTRONIC Inc.
7000 central avenue ne
minneapolis, MN 55432-3576
PMA NumberP960009
Supplement NumberS134
Date Received12/12/2011
Decision Date02/03/2012
Product Code
MHY[ Registered Establishments with MHY ]
Advisory Committee Neurology
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
APPROVAL FOR REMOVAL OF THE TUNNELING TOOL AND TUNNELING TOOL ACCESSORIES FROM DEEP BRAIN STIMULATION (DBS) EXTENSION KITS, MODELS 7472A AND 37085.
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