PMA P160054S104
- Device
- HeartMate 3™ Left Ventricular Assist System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P160054
- Supplement
- S104
- Product code
- DSQ
- Decision date
- 2025-10-06
- Classification
- Cardiovascular
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Approval for an update to the inspection specifications for the controller 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
- S104
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2025-10-06
- Decision code
- APPR
- Date received
- 2025-03-24
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for an update to the inspection specifications for the controller end bend relief on the HeartMate 3 (HM3) Modular Cable.