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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.
 
DeviceSPINAL CORD STIMULATION FAMILY OF NEUROSTIMULATION LEADS
Classification Namestimulator, spinal-cord, totally implanted for pain relief
Generic Namestimulator, spinal-cord, totally implanted for pain relief
Applicant
MEDTRONIC NEUROMODULATION
7000 central avenue ne
minneapolis, MN 55432
PMA NumberP840001
Supplement NumberS141
Date Received08/24/2009
Decision Date10/15/2009
Product Code
LGW[ Registered Establishments with LGW ]
Advisory Committee Neurology
Supplement Typenormal 180 day track no user fee
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR AN ALTERNATE MANUFACTURING SITE LOCATED AT BENCHMARK ELECTRONICS, INC., WINONA, MINNESOTA FOR THE MANUFACTURE OF THE MEDTRONIC MODEL 3625 TEST STIMULATOR.
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