|
Device | CONCERTO II/CONSULTA/MAXIMO II CRT-DS/CONCERTO |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P010031 |
Supplement Number | S203 |
Date Received | 06/18/2010 |
Decision Date | 07/16/2010 |
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 CHANGES IN PLATINUM FLOW ON COMPLEMENTARY METAL OXIDE SEMICONDUCTOR (CMOS) AT THE SUPPLIER LOCATION. |