Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
Device | SYNCARDIA TEMPORARY CARDIO WEST TOTAL ARTIFICIAL HEART (TAH-T) |
---|---|
Generic Name | Artificial heart |
Applicant | SYNCARDIA SYSTEMS, LLC 1992 E. SILVERLAKE RD. TUCSON, AZ 85713 |
PMA Number | P030011 |
Date Received | 04/11/2003 |
Decision Date | 10/15/2004 |
Product Code | LOZ |
Docket Number | 04M-0471 |
Notice Date | 10/27/2004 |
Advisory Committee | Cardiovascular |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE SYNCARDIA TEMPORARY CARDIO WEST TOTAL ARTIFICIAL HEART (TAH-T). THE DEVICE IS INDICATED FOR USE AS A BRIDGE TO TRANSPLANT IN CARDIAC TRANSPLANT-ELIGIBLE CANDIDATES AT RISK OF IMMINENT DEATH FROM BIVENTRICULAR FAILURE. ALSO, THE TEMPORARY CARDIOWEST TOTAL ARTIFICIAL HEART (TAH-T) IS INTENDED FOR USE INSIDE THE HOSPITAL. | |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling |
Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: | S026 S009 S010 S011 S027 S029 S023 S012 S035 S036 S022 S025 S007 S008 S002 S038 S039 S044 S054 S031 S019 S020 S037 S013 S015 S016 S030 S032 S033 S034 S024 S021 S001 S003 S006 S040 S041 S042 S043 S047 S048 S049 S050 S051 S052 S045 S046 S055 S057 S058 S059 S069 S070 S087 S060 S061 S056 S062 S064 S065 S066 S067 S068 S074 S076 S079 S077 S078 S071 S072 S073 S082 S084 S080 S089 S085 S086 S088 |