PMA P030011S045
- Device
- SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM
- Applicant
- Syncardia Systems, LLC
- PMA number
- P030011
- Supplement
- S045
- Product code
- LOZ
- Decision date
- 2016-09-21
- Classification
- Artificial Heart
- Generic name
- Artificial heart
- Approval order statement
- Addition of an alternate supplier for the AC Power Cord.
Current openFDA PMA Record#
- Device
- SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM
- Applicant
- Syncardia Systems, LLC
- PMA number
- P030011
- Supplement
- S045
- Product code
- LOZ
- Generic name
- Artificial heart
- Decision date
- 2016-09-21
- Decision code
- OK30
- Date received
- 2016-08-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of an alternate supplier for the AC Power Cord.