PMA P030011S043
- Device
- SYNCARDIA TEMPORARY CARDIO WEST TOTAL ARTIFICIAL HEART (TAH-T)
- Applicant
- Syncardia Systems, LLC
- PMA number
- P030011
- Supplement
- S043
- Product code
- LOZ
- Decision date
- 2016-04-27
- Classification
- Artificial Heart
- Generic name
- Artificial heart
- Approval order statement
- Approval for customer notifications regarding state of charge for batteries separate from consoles in air transportation.
Current openFDA PMA Record#
- Device
- SYNCARDIA TEMPORARY CARDIO WEST TOTAL ARTIFICIAL HEART (TAH-T)
- Applicant
- Syncardia Systems, LLC
- PMA number
- P030011
- Supplement
- S043
- Product code
- LOZ
- Generic name
- Artificial heart
- Decision date
- 2016-04-27
- Decision code
- APPR
- Date received
- 2016-03-30
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for customer notifications regarding state of charge for batteries separate from consoles in air transportation.