User Manual Part 1

Magnet Feature.......................................................................................................... 10-5
Explantati on...................................................................................................................... 10-8
PROGRAM MABLE OPTIONS.............. ........................................................................... .. A-1
APPENDIX A
PACEMAKER INTERACTION ........................................................................................... B-1
APPENDIX B
CLINICA L STUDY - MADIT II ...... ...................................................................................... C-1
APPENDIX C
Summary ................. ........................................................................................................... C-1
Indication s for Use............... ............................................................................................... C-1
Observed Adverse Events........................................................................... ....................... C-1
Mortality ....... .......................................................................................... ............................. C-6
Summary of Clinical Stu dy ................. ........................................................................... ..... C-6
Study Design .. .......................................................................................... .......................... C-7
Inclusion/ Exclusion Criteria ............. ................................................................................... C-8
Patient Sta tus ...................................................................................................................C-10
Primary Endpoint .................................................................................................. ............ C-10
Follow-up Schedule .......................................................................................................... C-11
Study Results ......................................................................... .......................................... C-12
CLINICA L STUDY - VENTAK AV II DR............................................................................. D-1
APPENDIX D
Clinical Study Populations .................................................................................................. D-1
Chronic Implant Study - VENTAK AV II DR ............. ........................................................... D-1
- DRAFT -