|
Device | CONCERTO CRT-D/CONSULTA CRT-D/MAXIMO II CRT-D |
Generic Name | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P010031 |
Supplement Number | S103 |
Date Received | 06/09/2008 |
Decision Date | 07/25/2008 |
Product Code |
NIK |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR MODIFICATIONS TO THE 9-PIN FILTERED FEEDTHROUGH USED IN VARIOUS FAMILIES OF MEDTRONIC ICD AND CRT-D DEVICES. |