PMA P060040S073
- Device
- HeartMate II Left Ventricular Assist System
- Applicant
- ABBOTT MEDICAL
- Product code
- DSQ
- Decision date
- 2020-01-27
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Approval for the HeartMate Touch Communication System.
Current openFDA PMA Record#
- Device
- HeartMate II Left Ventricular Assist System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P060040
- Supplement
- S073
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2020-01-27
- Decision code
- APPR
- Date received
- 2019-07-31
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the HeartMate Touch Communication System.