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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 ITREL SPINAL CORD STIMULATION SYSTEM
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 NumberS062
Date Received05/20/2002
Decision Date07/25/2002
Product Code
LGW[ Registered Establishments with LGW ]
Advisory Committee Neurology
Supplement Typereal-time process
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR THE MODEL 3550-16 EZ ANCHOR ACCESSORY KIT WHICH WILL BE LABELED FOR USE WITH THE FOLLOWING MEDTRONIC, INC. LEADS: PISCES-QUAD MODEL 3487A, RESUME MODEL 3587A, TEMPORARY SCREENING LEAD MODEL 3861, PISCES-QUAD COMPACT MODEL 3887, PISCES-QUAD PLUS MODEL 3888 AND THE PISCES-OCTAD MODEL 3898. THE MODEL 3550-16 EZ ANCHOR IS INDICATED AS AN AID IN THE MANAGEMENT OF CHRONIC, INTRACTABLE PAIN OF THE TRUNK OR LIMBS.
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