|
Device | CONCERTO/CONCERTO II/CONSULTA/INSYNC II MARQUIS/INSYNC III MARQUIS/INSYNC MAXIMO/INSYNC SENTRY/MAXIMO II |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P010031 |
Supplement Number | S233 |
Date Received | 01/25/2011 |
Decision Date | 02/24/2011 |
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 REVISION OF PARAMETERS TO AN EPOXY DISPENSE MANUFACTURING PROCESS. |