PMA P160054S028
- Device
- HeartMate 3™ (HM3) Left Ventricular Assist System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P160054
- Supplement
- S028
- Product code
- DSQ
- Decision date
- 2020-04-16
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Installation of additional data loggers for process monitoring at a manufacturing site.
Current openFDA PMA Record#
- Device
- HeartMate 3™ (HM3) Left Ventricular Assist System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P160054
- Supplement
- S028
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2020-04-16
- Decision code
- OK30
- Date received
- 2020-04-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Installation of additional data loggers for process monitoring at a manufacturing site.