|
Device | CONCERTO/CONCERTO II 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 | S132 |
Date Received | 11/04/2008 |
Decision Date | 05/01/2009 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR DESIGN AND MANUFACTURING PROCESS MODIFICATIONS TO THE EXISTING MEDTRONIC CARELINK MONITOR MODEL 2490C TO PRODUCE THE 2490C LOW COST MONITOR. |