|
Device | INSYNC SENTRY/III MARQUIS/II MARQUIS/MAXIMO/CONCERTO ICDS/CONSULTA/MAXIMO II/CONCERTO II CRT-DS |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P010031 |
Supplement Number | S212 |
Date Received | 07/23/2010 |
Decision Date | 08/20/2010 |
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 UPGRADE TO THE CAPACITORS HELIUM LEAK TEST STATION. |