|
Device | CONCERTO/CONCERTO II/CONSULTA/INSYNC II/III MARQUIS/MAXIMO/SENTRY/MAXIMO II/PROTECTA/PROTECTA XT |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P010031 |
Supplement Number | S258 |
Date Received | 06/08/2011 |
Decision Date | 07/07/2011 |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Recalls | CDRH Recalls |
Approval Order Statement UPGRADE TO STATISTICAL PROCESS CONTROL OFF-THE-SHELF SOFTWARE THAT WILL BE USED BY MEDTRONIC ENERGY AND COMPONENT CENTER (MECC). |