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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(R) & ITREL(R) SPINAL CORD STIM SYS
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantMedtronic Neuromodulation
7000 Central Ave., NE
Minneapolis, MN 55432
PMA NumberP840001
Supplement NumberS036
Date Received12/20/1994
Decision Date07/13/1995
Product Code LGW 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR RELOCATION OF THE STERILIZATION/PACKAGING FACILITY & A MODIFICATION IN THE STERILIZATION PROCESS FOR MODELS:7491,7492,7493,7494,7495,7496 & ASSOCIATED LEADS,RECEIVERS, & ACCESSORIES NEW FACILITY:COLUMBIA HEIGHTS,MINNESOTA 55421
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