PMA P030011S037
- Device
- SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM
- Applicant
- Syncardia Systems, LLC
- PMA number
- P030011
- Supplement
- S037
- Product code
- LOZ
- Decision date
- 2016-01-07
- Classification
- Artificial Heart
- Generic name
- Artificial heart
- Approval order statement
- CHANGE IN THE ASSEMBLER AND REPLACEMENT OF COMPONENTS FOR THE FREEDOM DRIVER MAIN PRINTED CIRCUIT BOARD ASSEMBLY.
Current openFDA PMA Record#
- Device
- SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM
- Applicant
- Syncardia Systems, LLC
- PMA number
- P030011
- Supplement
- S037
- Product code
- LOZ
- Generic name
- Artificial heart
- Decision date
- 2016-01-07
- Decision code
- OK30
- Date received
- 2015-12-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE IN THE ASSEMBLER AND REPLACEMENT OF COMPONENTS FOR THE FREEDOM DRIVER MAIN PRINTED CIRCUIT BOARD ASSEMBLY.