|
Device | CONCERTO/II/CONSULTA/INSYNC ICD/MARQUIS/MAXIMO/INSYNC II/MARQUIS/MAXIMO II/INSYNC II PROTECT/III MARQUIS/SENTRY |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 coral sea street n.e. mounds view, MN 55112 |
PMA Number | P010031 |
Supplement Number | S192 |
Date Received | 03/29/2010 |
Decision Date | 04/28/2010 |
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 ADDITION OF A BUSINESS RULE TO THE MANUFACTURING EXECUTION SYSTEM. |