|
Device | CONCERTO II/CONSULTA/INSYNC II MARQUIS/III MARQUIS/INSYNC 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 | S251 |
Date Received | 04/26/2011 |
Decision Date | 05/19/2011 |
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 USE OF MES WEB SERVICES; REPLACING THE PAPER LOGS WITH ELECTRONIC DATA LOGS; AND A MODIFICATION OF THE DEFAULT LOT SIZE IN NEW WORK ORDERS. |