|
Device | INSYNC/INSYNC II/III MARQUIS/INSYNC SENTRY/MAXIMO ICDS/CONCERTO/II/MAXIMO II/CONSULTA/PROTECTA XT/PROTECTA/PROTECTA DF4 |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P010031 |
Supplement Number | S286 |
Date Received | 12/20/2011 |
Decision Date | 01/18/2012 |
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 IMPLEMENTATION OF THERMAL PROCESSING FOR A MANUFACTURING COMPONENT USED DURING ROUTINE MANUFACTURING. |