SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM
FDA premarket approval P030011/S012 · decided 2012-06-26
Approval details
- PMA number
- P030011
- Supplement
- S012
- 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
- 2012-04-09
- Decision date
- 2012-06-26
- Days to decision
- 78 days
- Decision code
- APPR
- Product code
- LOZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tucson, AZ
- Statement
- APPROVAL FOR RELOCATION OF A POLYMER MANUFACTURING PROCESS.
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