|
Device | CONSULTA CRT-D & MAXIMO II CRT-D |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 coral sea street n.e. mounds view, MN 55112 |
PMA Number | P010031 |
Supplement Number | S111 |
Date Received | 07/17/2008 |
Decision Date | 08/15/2008 |
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 FIVE MODIFICATIONS TO THE FINAL FUNCTIONAL ELECTRICAL TESTING FOR THE DEVICES. |