PMA P030011S035
- Device
- SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM
- Applicant
- Syncardia Systems, LLC
- PMA number
- P030011
- Supplement
- S035
- Product code
- LOZ
- Decision date
- 2015-10-29
- Classification
- Artificial Heart
- Generic name
- Artificial heart
- Approval order statement
- AN ALTERNATE ASSEMBLER FOR CERTAIN FREEDOM DRIVER PRINTED CIRCUIT BOARD ASSEMBLIES.
Current openFDA PMA Record#
- Device
- SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM
- Applicant
- Syncardia Systems, LLC
- PMA number
- P030011
- Supplement
- S035
- Product code
- LOZ
- Generic name
- Artificial heart
- Decision date
- 2015-10-29
- Decision code
- OK30
- Date received
- 2015-09-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- AN ALTERNATE ASSEMBLER FOR CERTAIN FREEDOM DRIVER PRINTED CIRCUIT BOARD ASSEMBLIES.