|
Device | INSYNC III MARQUIS/PROTECT/INSYNC SENTRY/MAXIMO ICD/CONCERTO/II/MAXIMO II/CONSULTA CRT-D |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P010031 |
Supplement Number | S188 |
Date Received | 02/18/2010 |
Decision Date | 03/19/2010 |
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 CHANGE IN HOW THE INSTALLATION AND CONFIGURATION OF THE APPLICATION SOFTWARE FOR THE AUTOMATED ACCELEROMETER TEST SYSTEM WAS CONTROLLED. |