|
Device | CONCERTO II/MAXIMO II/CONSULTA CRT-DS |
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 | S228 |
Date Received | 01/04/2011 |
Decision Date | 05/13/2011 |
Product Code |
NIK |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Review Memo | Review Memo |
Approval Order Statement APPROVAL FOR THE MEDTRONIC MODEL 9986 DESKTOP/ BOSS VERSION 2.4 FOR USE ON THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER. |
Approval Order | Approval Order |