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 | ACTIVARC AND ACTIVAPC |
Generic Name | Stimulator, electrical, implanted, for parkinsonian tremor |
Applicant | MEDTRONIC Inc. 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432-3576 |
PMA Number | P960009 |
Supplement Number | S067 |
Date Received | 04/15/2009 |
Decision Date | 06/08/2009 |
Product Code |
MHY |
Advisory Committee |
Neurology |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR MODEL 64001 (1X4) POCKET ADAPTOR AND MODEL 64002 (2X4) POCKET ADAPTOR. |
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