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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 INTERSTIM SACRAL NERVE STIMULATION (SNS) SYSTEM FOREMAN NEEDLE
Generic NameStimulator, electrical, implantable, for incontinence
Regulation Number876.5270
ApplicantMedtronic Neuromodulation
7000 Central Ave., NE
Minneapolis, MN 55432
PMA NumberP970004
Supplement NumberS029
Date Received08/30/2004
Decision Date08/04/2005
Product Code EZW 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day 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: 1) SHIPMENT OF PATIENT CABLE (MODEL 041831) AFTER MANUFACTURING TO MEDTRONIC NEUROLOGICAL DIVISION, SULLIVAN LAKE FACILITY, MINNEAPOLIS, MINNESOTA, FOR CLEANING, PACKAGING AND ETHYLENE OXIDE STERILIZATION, 2) EXTENSION OF THE CURRENT 2-YEAR SHELF LIFE OF THE PATIENT CABLE TO 4 YEARS USING ETHYLENE OXIDE STERILIZATION AND 3) LABELING CHANGES THAT INVOLVE COMBINING THE SEPARATE MANUALS FOR THE MODEL 3065U KIT AND THE MODEL 3057 LEAD INTO ONE MANUAL AND TO REPLACE THE COMBINED MANUAL FOR MODELS 041831, 041829, 041828, 041827 AND 041826 WITH SEPARATE SINGLE SHEET IFUS (INFORMATION FOR USE).
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