PMA P160054S010
- Device
- HeartMate 3™ Left Ventricular Assist System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P160054
- Supplement
- S010
- Product code
- DSQ
- Decision date
- 2018-05-18
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Approval for an update to the Instructions for Use regarding Outflow Graft twist obstruction.
Current openFDA PMA Record#
- Device
- HeartMate 3™ Left Ventricular Assist System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P160054
- Supplement
- S010
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2018-05-18
- Decision code
- APPR
- Date received
- 2018-05-16
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for an update to the Instructions for Use regarding Outflow Graft twist obstruction.