|
Device | INSYNC/INSYNC MARQUIS/INSYNC II/III MARQUIS/INSYNC II PROTECT/SENTRY/MAXIMO ICDS/CONCERTO/II/MAXIMO II/CONSULTA CRT-DS |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P010031 |
Supplement Number | S224 |
Date Received | 12/09/2010 |
Decision Date | 01/07/2011 |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement RELOCATION OF A STERILIZER SYSTEM WITHIN AN EXISTING LOCATION. |