|
Device | CONCERTO II ICD/CONSULTA CRT-D/MAXIMO II CRT-D CONCERTO |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P010031 |
Supplement Number | S216 |
Date Received | 09/16/2010 |
Decision Date | 10/15/2010 |
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 ADDITION OF A SECOND SUPPLIER FOR THE BPA COMPONENT AND A CHANGE IN THE COMPONENT INSPECTION PROCESS. |