PMA P030011S086
- Device
- SynCardia temporary Total Artificial Heart (TAH-t) System
- Applicant
- Syncardia Systems, LLC
- PMA number
- P030011
- Supplement
- S086
- Product code
- LOZ
- Decision date
- 2023-08-09
- Classification
- Cardiovascular
- Generic name
- Artificial heart
- Approval order statement
- Change the Loctite used internally in the Freedom Driver of the SynCardia temporary Total Artificial Heart System.
Current openFDA PMA Record#
- Device
- SynCardia temporary Total Artificial Heart (TAH-t) System
- Applicant
- Syncardia Systems, LLC
- PMA number
- P030011
- Supplement
- S086
- Product code
- LOZ
- Generic name
- Artificial heart
- Decision date
- 2023-08-09
- Decision code
- OK30
- Date received
- 2023-07-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change the Loctite used internally in the Freedom Driver of the SynCardia temporary Total Artificial Heart System.