PMA P060040S055
- Device
- THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM
- Applicant
- ABBOTT MEDICAL
- PMA number
- P060040
- Supplement
- S055
- Product code
- DSQ
- Decision date
- 2016-04-28
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Add a new sterilization chamber for certain components of the Thoratec HeartMate II® Ventricular Assist System.
Current openFDA PMA Record#
- Device
- THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM
- Applicant
- ABBOTT MEDICAL
- PMA number
- P060040
- Supplement
- S055
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2016-04-28
- Decision code
- OK30
- Date received
- 2016-03-31
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add a new sterilization chamber for certain components of the Thoratec HeartMate II® Ventricular Assist System.