|
Device | CONCERTO II/MAXIMO II/CONSULTA/CONCERTO CRT-DS/INSYNC MAXIMO/SENTRY/INSYNC II MARQUIS/INSYNC III MARQUIS ICDS |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 coral sea street n.e. mounds view, MN 55112 |
PMA Number | P010031 |
Supplement Number | S231 |
Date Received | 01/18/2011 |
Decision Date | 02/17/2011 |
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 IMPLEMENTATION OF A DETECTION STEP IN THE BATTERY MANUFACTURING PROCESS AT A SUPPLIER. |