|
Device | VIRTUOSO MODELS D154AWG/D154VWC |
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 | S090 |
Date Received | 11/28/2006 |
Decision Date | 02/15/2007 |
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 FIRMWARE UPDATES TO 1) ADDRESS A ?SOFT? RATE LIMIT POWER ON RESET, 2) LOAD A TEMPERATURE SENSITIVITY UPDATE AT THE TIME OF MANUFACTURING, AND 3) LOAD OPTIVOL ENHANCEMENTS (FOR USE OUTSIDE OF THE UNITED STATES ONLY) AT THE TIME OF MANUFACTURING. |