SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART
FDA premarket approval P030011/S027 · decided 2014-09-12
Approval details
- PMA number
- P030011
- Supplement
- S027
- 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
- 2014-08-04
- Decision date
- 2014-09-12
- Days to decision
- 39 days
- Decision code
- APPR
- Product code
- LOZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tucson, AZ
- Statement
- APPROVAL FOR SEVERAL DESIGN CHANGES TO THE SYNCARDIA COMPANION 2DRIVER PRESSURE SENSOR PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) AND THE ADDITION OF AN ALTERNATE SUPPLIER FOR THE PRESSURE SENSOR PCBA.
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