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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 NumberS371
Date Received04/09/2013
Decision Date05/07/2013
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
SEVEN PREVIOUSLY APPROVED MANUFACTURE CHANGES FOR THE DEVICES. THOSE ARE:1) UPDATE THE CMOS IC PROCESS FLOW CHANGES AT YOUR SUPPLIER; 2) UPDATE THE TEST SOFTWARE AND HARDWARE ON THE TERADYNE TEST PLATFORM FOR M019 AND M017 ICS;3) ADD THE HIGH TEMPERATURE MONITOR TO HIGH POWER LEAN LINE; 4) UPDATE THE AUTOMATED ASSEMBLY EQUIPMENT CONTROLLER (AAEC); 5) IMPLEMENT A NEW CLEANING PROCESS AND A CURING OVEN; 6) IMPLEMENT A MANUFACTURING EXECUTION SYSTEM VERSION 7.9 AT VARIOUS INTERNAL SUPPLIERS AND FINAL DEVICE MANUFACTURING LOCATIONS; AND7) UPDATE TO THE TEST SYSTEM SOFTWARE SHELL.
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