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. |
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Device | DEEP BRAIN STIMULATION (DBS) EXTENSION KITS |
Generic Name | Stimulator, electrical, implanted, for parkinsonian tremor |
Applicant | MEDTRONIC Inc. 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432-3576 |
PMA Number | P960009 |
Supplement Number | S134 |
Date Received | 12/12/2011 |
Decision Date | 02/03/2012 |
Product Code |
MHY |
Advisory Committee |
Neurology |
Supplement Type | Real-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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