PMA P030011S040
- Device
- SYNCARDIA TEMPORARY CARDIO WEST TOTAL ARTIFICIAL HEART (TAH-T)
- Applicant
- Syncardia Systems, LLC
- PMA number
- P030011
- Supplement
- S040
- Product code
- LOZ
- Decision date
- 2016-03-22
- Classification
- Artificial Heart
- Generic name
- Artificial heart
- Approval order statement
- Change in the heat spreader used in the Companion 2 Driver Single Board Computer (SBC).
Current openFDA PMA Record#
- Device
- SYNCARDIA TEMPORARY CARDIO WEST TOTAL ARTIFICIAL HEART (TAH-T)
- Applicant
- Syncardia Systems, LLC
- PMA number
- P030011
- Supplement
- S040
- Product code
- LOZ
- Generic name
- Artificial heart
- Decision date
- 2016-03-22
- Decision code
- OK30
- Date received
- 2016-02-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in the heat spreader used in the Companion 2 Driver Single Board Computer (SBC).