|
Device | CONCERTO/II/CONSULTA/INSYNC II/III MARQUIS/INSYNC MAXIMO/INSYNC SENTRY/MAXIMO II CRT-DS |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P010031 |
Supplement Number | S184 |
Date Received | 02/04/2010 |
Decision Date | 03/05/2010 |
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 CHANGE IN A VENDOR¿S EPITAXY SUPPLIER. |