|
Device | INSYNC III/II MARQUIS CRT-D/INSYNC SENTRY/MAXIMO CRT-D/CONCERTO/CONSULTA/CONCERTO II/MAXIMO II CRT-D |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P010031 |
Supplement Number | S219 |
Date Received | 10/26/2010 |
Decision Date | 11/23/2010 |
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 IMPLEMENTATION OF AN UPDATED VERSION OF THE STATISTICAL PROCESS CONTROL (SPC) SOFTWARE SYSTEM ACROSS MULTIPLE MANUFACTURING LOCATIONS AND VERTICALLY INTEGRATED SUPPLIERS. |