PMA P160054S038
- Device
- HeartMate 3™ Left Ventricular Assist System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P160054
- Supplement
- S038
- Product code
- DSQ
- Decision date
- 2021-10-07
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Alternate leakage Test Analyzer for HeartMate Power Module (PM) and HeartMate Universal Battery Charger (UBC).
Current openFDA PMA Record#
- Device
- HeartMate 3™ Left Ventricular Assist System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P160054
- Supplement
- S038
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2021-10-07
- Decision code
- OK30
- Date received
- 2021-09-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Alternate leakage Test Analyzer for HeartMate Power Module (PM) and HeartMate Universal Battery Charger (UBC).