|
Device | SECURA DR/VR MAXIMO II DR/VR AND VIRTUOSO II DR/VR |
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 | S164 |
Date Received | 10/22/2008 |
Decision Date | 03/31/2009 |
Product Code |
LWS |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT00279279
|
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE MODEL 9995 V1.2 APPLICATION SOFTWARE WHICH INCLUDES THE LEAD INTEGRITY ALERT FEATURE AND ADDITIONAL SOFTWARE UPDATES. |