|
Device | INSYNC/INSYNC MARQUIS/II/III/INSYNC II PROTECT/III/INSYNC SENTRY/INSYNC MAXIMO ICDS/CONCERTO/II/MAXIMO/CONSULTA CRT-DS |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P010031 |
Supplement Number | S182 |
Date Received | 01/21/2010 |
Decision Date | 02/19/2010 |
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 THE CLEAN ROOM MONITORING FREQUENCY. |