PMA P060040S054
- Device
- THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM
- Applicant
- ABBOTT MEDICAL
- PMA number
- P060040
- Supplement
- S054
- Product code
- DSQ
- Decision date
- 2016-04-05
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Approval for adding an informational card related to the backup battery.
Current openFDA PMA Record#
- Device
- THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM
- Applicant
- ABBOTT MEDICAL
- PMA number
- P060040
- Supplement
- S054
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2016-04-05
- Decision code
- APPR
- Date received
- 2016-03-28
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for adding an informational card related to the backup battery.