SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART
FDA premarket approval P030011/S007 · decided 2010-04-28
Approval details
- PMA number
- P030011
- Supplement
- S007
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART
- Generic name
- Artificial heart
- Applicant
- Syncardia Systems, LLC
- Date received
- 2010-01-15
- Decision date
- 2010-04-28
- Days to decision
- 103 days
- Decision code
- APPR
- Product code
- LOZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tucson, AZ
- Statement
- APPROVAL FOR THE TRADE NAME CHANGE OF THE SUBJECT DEVICE. THE DEVICE WILL BE MARKETED UNDER THE TRADE NAME SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART AND IS INDICATED FOR USE IN TRANSPLANT-ELIGIBLE CANDIDATES IN IMMINENT DANGER OF DEATH FROM IRREVERSIBLE BIVENTRICULAR FAILURE.
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