|
Device | CONCERTO CRT ICD/CONSULTA CRT-D/MAXIMO II CRT-D/CONCERTO II CRT-D |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P010031 |
Supplement Number | S173 |
Date Received | 11/27/2009 |
Decision Date | 12/23/2009 |
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 RADIO FREQUENCY DEVICE TEST CHANGES ON THE AUTOMATED TEST EQUIPMENT APPLICATION SOFTWARE. |