|
Device | MEDTRONIC SECURA DR/VR D224DRG/ D224VRC, MAXIMO DR/VR D284DRG/ D284VRC, VIRTUOSO II DR/VR D274DRG/ D274VRC |
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 | S234 |
Date Received | 03/31/2010 |
Decision Date | 05/11/2010 |
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 UPDATES MADE TO THE PROGRAMMER APPLICATION SOFTWARE MODEL 9995 AND THE CARELINK DEVICE DATA MANAGEMENT APPLICATION (DDMA) IN RESPONSE TO ADVERSE FIELD EVENTS. |