SYNCARDIA TEMPORARY CARDIO WEST TOTAL ARTIFICIAL HEART (TAH-T)
FDA premarket approval P030011/S043 · decided 2016-04-27
Approval details
- PMA number
- P030011
- Supplement
- S043
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SYNCARDIA TEMPORARY CARDIO WEST TOTAL ARTIFICIAL HEART (TAH-T)
- Generic name
- Artificial heart
- Applicant
- Syncardia Systems, LLC
- Date received
- 2016-03-30
- Decision date
- 2016-04-27
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- LOZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tucson, AZ
- Statement
- Approval for customer notifications regarding state of charge for batteries separate from consoles in air transportation.
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