|
Device | MEDTRONIC IMPLANTABLE CARDIO-VERTER DEFIBRILLATOR SYSTEMS ENTRUST ICOS |
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 | S058 |
Date Received | 10/05/2005 |
Decision Date | 11/15/2005 |
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 1) MEDTRONIC MODEL 2490G CARELINK MONITOR, MODEL 2020A CARDIOSIGHT READER AND MODEL 2491 DDMA SOFTWARE TO SUPPORT THE ENTRUST ICDS 2) TO MAKE OPTIVOL INFORMATION WITHOUT THE THRESHOLD LINE AVAILABLE FOR INSYNC SENTRY MODELS 7297 AND 7299 VIEWABLE BY PHYSICIANS USING THE CARELINK NETWORK. |