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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.
 
DeviceBRAVA CRT-D,VIVA S CRT-D,VIVA XT CRT-D
ApplicantMEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
8200 CORAL SEA STREET N.E.
MOUNDS VIEW, MN 55112
PMA NumberP010031
Supplement NumberS357
Date Received02/07/2013
Decision Date03/07/2013
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
MULTIPLE MANUFACTURING CHANGES PREVIOUSLY ACCEPTED FOR OTHER MARKET RELEASED MEDTRONIC DEVICES, WHICH INCLUDED: 1) CMOS PROCESS FLOW CHANGES AT YOUR SUPPLIER; 2) UPDATES TO THE TEST SOFTWARE AND HARDWARE FOR INTEGRATED CIRCUITS; 3) ADDITION OF HIGH TEMPERATURE MONITORING TO THE HIGH POWER LEAN LINE; 4) UPDATE TO A MANUFACTURING ASSEMBLY CONTROLLER SYSTEM; 5) IMPLEMENTATION OF A NEW CLEANING PROCESS AND CURING OVEN; AND 6) AND IMPLEMENTATION OF THE MANUFACTURING EXECUTION SYSTEM VERSION 7.9 AT VARIOUS INTERNAL SUPPLIERS AND FINAL DEVICE MANUFACTURING LOCATIONS.
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