PMA P160054S127
- Device
- HeartMate 3™ Left Ventricular Assist System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P160054
- Supplement
- S127
- Product code
- DSQ
- Decision date
- 2026-07-01
- Classification
- Cardiovascular
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- update to the inspection specifications for the in-line connection end bend relief on the HeartMate 3 (HM3) Modular Cable
Current openFDA PMA Record#
- Device
- HeartMate 3™ Left Ventricular Assist System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P160054
- Supplement
- S127
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2026-07-01
- Decision code
- OK30
- Date received
- 2026-06-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- update to the inspection specifications for the in-line connection end bend relief on the HeartMate 3 (HM3) Modular Cable