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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.
 
DeviceSNS URINARY ACCESSORIES, EXTENSION, LEADS URINRY NEUROSTIMULATOR IMPLANTABLE INTERSTRIM FAMILY, URINARY SCREENING TRIAL
Generic NameStimulator, electrical, implantable, for incontinence
Regulation Number876.5270
ApplicantMEDTRONIC NEUROMODULATION
7000 CENTRAL AVENUE, N.E.
MINNEAPOLIS, MN 55432
PMA NumberP970004
Supplement NumberS161
Date Received09/23/2013
Decision Date10/22/2013
Product Code EZW 
Advisory Committee Gastroenterology/Urology
Supplement Type30-Day Notice
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
INCREASE THE USE BEFORE DATE STORAGE SHELF LIFE OF THE TYVEK LID PACKAGING COMPONENT USED IN THE STERILE PACKAGING CONFIGURATION OF MULTIPLE IMPLANTABLE NEUROMODULATION PRODUCTS.
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