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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.
 
DeviceBLACKWELL BATTERY UBITS (UNIVERSAL BURN-IN TEST SYSTEM)
ApplicantMedtronic Cardiac Rhythm Disease Management
8200 Coral Sea St. N.E
Mounds View, MN 55112
PMA NumberP010031
Supplement NumberS354
Date Received02/06/2013
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
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
THREE CHANGES INCLUDING THE IMPLEMENTATION OF A BURN-IN OVEN FOR THE RECOVERY AND FINAL VOLTAGE MEASUREMENTS STEPS FOR THE BATTERIES OF THE SUBJECT CRT-D SYSTEMS, CORRECTIONS TO THE SUBJECT SYSTEMS¿ BATTERY TEST SPECIFICATION TO ALIGN WITH MEASUREMENT SYSTEM CAPABILITIES, AND CONSOLIDATION OF MEASUREMENT STEPS WITHIN THE BURN IN TEST PROCESS.
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