SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM
FDA premarket approval P030011/S008 · decided 2010-10-26
Approval details
- PMA number
- P030011
- Supplement
- S008
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM
- Generic name
- Artificial heart
- Applicant
- Syncardia Systems, LLC
- Date received
- 2010-06-21
- Decision date
- 2010-10-26
- Days to decision
- 127 days
- Decision code
- APPR
- Product code
- LOZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tucson, AZ
- Statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
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