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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.
 
DeviceITREL, SYNERGY AND SYNERGY VERSITREL NEUROSTIMULATORS
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantMedtronic Neuromodulation
7000 Central Ave., NE
Minneapolis, MN 55432
PMA NumberP840001
Supplement NumberS068
Date Received04/07/2003
Decision Date05/09/2003
Product Code LGW 
Advisory Committee Neurology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR LABELING CHANGES TO PISCES Z QUAD LEAD TECHNICAL MANUALS AND A CHANGE TO THE NEEDLE IN THE PISCES Z QUAD LEAD KITS AND IN THE MODEL 3550-22 AND MODEL 3550-23 ACCESSORY KITS FROM 15 GAUGE TO THE 14 GAUGE.
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