|
Device | INSYNC MARQUIS/SENTRY/MAXIMO/CONCERTO & VIRTUOSO CRT-ICDS |
Generic Name | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P010031 |
Supplement Number | S061 |
Date Received | 12/20/2006 |
Decision Date | 01/30/2007 |
Product Code |
NIK |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE MEDTRONIC MODELS 2490G (REV. T APPLICATION SOFTWARE VERSION 5V3); MEDTRONIC 2020A CARDIOSIGHT READER (APPLICATION SOFTWARE VERSION 5V3); AND MEDTRONIC 2491 DDMA SOFTWARE. THE MEDTRONIC 2491 DDMA SOFTWARE CONTAINS THE XML TRANSLATION UTILITY (XMLTU) SOFTWARE VERSION V17, THE PRESENTING WAVEFORM UTILITY (PWF) SOFTWARE VERSION 16V1, AND THE SESSION DATA DECODE (SDD) SOFTWARE VERSION 1V2. |