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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.
 
DeviceCAPSURE/STERX TIP PACING/CAPSURE Z/SP NOVUS/VITATRON IMPULSE/II/VITATRON EXCELLENCE S+/VITATRON EXCELLENCE SS+ LEAD DRUG
Generic NamePermanent defibrillator electrodes
ApplicantMEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
8200 CORAL SEA STREET N.E.
MOUNDS VIEW, MN 55112
PMA NumberP850089
Supplement NumberS071
Date Received10/26/2010
Decision Date11/23/2010
Product Code NVY 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
IMPLEMENTATION OF AN UPDATED VERSION OF THE STATISTICAL PROCESS CONTROL (SPC) SOFTWARE SYSTEM ACROSS MULTIPLE MANUFACTURING LOCATIONS AND VERTICALLY INTEGRATED SUPPLIERS.
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