|
Device | INSYNC/MARQUIS/II & III MARQUIS/II PROTECT/SENTRY/MAXIMO ICDS & CONCERTO/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 | S196 |
Date Received | 05/03/2010 |
Decision Date | 06/02/2010 |
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 RELOCATION OF AN ETHYLENE OXIDE STERILIZER. |