SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM
FDA premarket approval P030011/S038 · decided 2016-02-22
Approval details
- PMA number
- P030011
- Supplement
- S038
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM
- Generic name
- Artificial heart
- Applicant
- Syncardia Systems, LLC
- Date received
- 2015-12-31
- Decision date
- 2016-02-22
- Days to decision
- 53 days
- Decision code
- APPR
- Product code
- LOZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tucson, AZ
- Statement
- Approval for a location change for a secondary supplier as well as the addition of 3 new machines at the same secondary supplier.
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