SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART
FDA premarket approval P030011/S022 · decided 2013-12-13
Approval details
- PMA number
- P030011
- Supplement
- S022
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART
- Generic name
- Artificial heart
- Applicant
- Syncardia Systems, LLC
- Date received
- 2013-11-13
- Decision date
- 2013-12-13
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LOZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tucson, AZ
- Statement
- CHANGE IN THE MANUFACTURING SITE OF THE INTERNAL BATTERY OF THE COMPANION 2 DRIVER SYSTEM.
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