|
Device | CONCERTO, CONCERTO2 CONSULTA AND MAXIMO 2 |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 CORAL SEA STREET N.E. MS MVS11 MOUNDS VIEW, MN 55112 |
PMA Number | P980016 |
Supplement Number | S252 |
Date Received | 07/08/2010 |
Decision Date | 09/29/2010 |
Product Code |
LWS |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE DESIGN CHANGES TO NPO-0402 MULTILAYER CERAMIC CAPACITORS (XC269 AND XC313). |