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Device | BLACKWELL BATTERY UBITS (UNIVERSAL BURN-IN TEST SYSTEM) |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P010031 |
Supplement Number | S354 |
Date Received | 02/06/2013 |
Decision Date | 03/07/2013 |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
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. |