SynCardia temporary Total Artificial Heart System
FDA premarket approval P030011/S079 · decided 2020-10-28
Approval details
- PMA number
- P030011
- Supplement
- S079
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SynCardia temporary Total Artificial Heart System
- Generic name
- Artificial heart
- Applicant
- Syncardia Systems, LLC
- Date received
- 2020-09-30
- Decision date
- 2020-10-28
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LOZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tucson, AZ
- Statement
- Supplier change of Freedom Driver injection molded parts.
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