SynCardia temporary Total Artificial Heart (TAH-t) System- Companion 2 Driver System
FDA premarket approval P030011/S062 · decided 2018-07-04
Approval details
- PMA number
- P030011
- Supplement
- S062
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SynCardia temporary Total Artificial Heart (TAH-t) System- Companion 2 Driver System
- Generic name
- Artificial heart
- Applicant
- Syncardia Systems, LLC
- Date received
- 2018-06-14
- Decision date
- 2018-07-04
- Days to decision
- 20 days
- Decision code
- OK30
- Product code
- LOZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tucson, AZ
- Statement
- Change of manufacturer for the electrical assemblies for the Companion 2 Driver.
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