PMA P160054S133
- Device
- HeartMate 3 Left Ventricular Assist System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P160054
- Supplement
- S133
- Product code
- DSQ
- Decision date
- 2026-08-20
- Classification
- Cardiovascular
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- manufacturing and inspection process changes to the motor PCBA bearing and drive coils
Current openFDA PMA Record#
- Device
- HeartMate 3 Left Ventricular Assist System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P160054
- Supplement
- S133
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2026-08-20
- Decision code
- OK30
- Date received
- 2026-07-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- manufacturing and inspection process changes to the motor PCBA bearing and drive coils