PMA P060040S052
- Device
- THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM
- Applicant
- ABBOTT MEDICAL
- PMA number
- P060040
- Supplement
- S052
- Product code
- DSQ
- Decision date
- 2016-06-17
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Approval for revisions to the user interface of the HeartMate II (HM II) LVAS System Monitor.
Current openFDA PMA Record#
- Device
- THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM
- Applicant
- ABBOTT MEDICAL
- PMA number
- P060040
- Supplement
- S052
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2016-06-17
- Decision code
- APPR
- Date received
- 2016-02-22
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for revisions to the user interface of the HeartMate II (HM II) LVAS System Monitor.