SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART
FDA premarket approval P030011/S030 · decided 2015-02-12
Approval details
- PMA number
- P030011
- Supplement
- S030
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART
- Generic name
- Artificial heart
- Applicant
- Syncardia Systems, LLC
- Date received
- 2014-11-20
- Decision date
- 2015-02-12
- Days to decision
- 84 days
- Decision code
- APPR
- Product code
- LOZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tucson, AZ
- Statement
- APPROVAL FOR A MINOR DESIGN CHANGE TO THE FREEDOM DRIVER AC POWER SUPPLY.
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