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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.
 
DeviceMEDTRONIC ACTIVA PARKINSON CONTROL SYSTEM
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 NumberS024
Date Received02/25/2002
Decision Date07/29/2002
Product Code
MHY[ Registered Establishments with MHY ]
Advisory Committee Neurology
Supplement Typereal-time process
Supplement Reason other report
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR MINOR CHANGES TO THE LABELING OF THE EXISTING MEDTRONIC ACCESS REVIEW MODEL 7438 THERAPY CONTROLLER TO BE USED WITH MEDTRONIC ACTIVA PARKINSON'S CONTROL SYSTEM.
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