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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.
 
DeviceITRELL 3, SYNERGY AND SYNGERY VERSITREL SPINAL CORD STIMULATION SYSTEMS
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantMedtronic Neuromodulation
7000 Central Ave., NE
Minneapolis, MN 55432
PMA NumberP840001
Supplement NumberS072
Date Received03/04/2004
Decision Date04/15/2004
Product Code LGW 
Advisory Committee Neurology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL TO USE EALSTHANE RESINS AS ALTERNATE MATERIALS TO PELLETHANE RESINS IN LEADS, EXTENSIONS AND ACCESSORIES. THE FOLLOWING LEADS, EXTENSIONS AND ACCESSORIES WILL BE AFFECTED: MODEL 3487A - PISCES QUAD, MODEL 3887 - PISCES QUAD COMPACT, MODEL 3888 - PISCES QUAD PLUS, MODEL 3890 - PISCES Z QUAD, MODEL 3891 - PISCES Z QUAD COMPACT, MODEL 3892 - PISCES Z QUAD PLUS, MODEL 3898 - PISCES OCTAD, MODEL 3998 - SPECIFY, MODEL 3982A - SYMMIX, MODEL 3861 - TEMPORARY SCREENING LEAD, MODEL 3862 - VERIFY, MODEL 3587A - RESUME II, MODEL 3986A RESUMETL, MODEL 7471 EXTENSION, MODEL 7489 EXTENSION, MODEL 7495 EXTENSION, MODEL 7495LZ EXTENSION, MODEL 7496 EXTENSION, MODEL 7498 EXTENSION, MODEL 3550-09 - ACCESSORY KIT, MODEL 7441 - ACCESSORY KIT AND MODEL 7441NC - ACCESSORY KIT.
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