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U.S. Department of Health and Human Services

Devices@FDA
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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.
 
DeviceINTERSTIM SACRAL NERVE STIMULATION SYSTEM
Generic NameStimulator, electrical, implantable, for incontinence
Regulation Number876.5270
ApplicantMedtronic Neuromodulation
7000 Central Ave., NE
Minneapolis, MN 55432
PMA NumberP970004
Supplement NumberS010
Date Received06/20/2000
Decision Date06/28/2000
Product Code EZW 
Advisory Committee Gastroenterology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR 1) INCLUSION OF DEPTH INDICATORS ALONG THE BODY OF THE MODEL 3057 TEST STIMULATION LEAD AND ASSOCIATED LABELING CHANGES (3057 TEST STIMULATION COMPONENTS MANUAL AND 3065U MANUAL), AND 2) OTHER MINOR LABELING CHANGES TO THESE MANUALS FOR CLARIFICATION OF INSTRUCTIONS AND MINOR REFINEMENTS TO THE LEAD TESTING SPECIFICATIONS.
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