PMA P160054S130
- Device
- HeartMate 3™ Left Ventricular Assist System (LVAS)
- Applicant
- ABBOTT MEDICAL
- PMA number
- P160054
- Supplement
- S130
- Product code
- DSQ
- Decision date
- 2026-07-30
- Classification
- Cardiovascular
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- the addition of an alternate supplier for the Graft Nut and Locking Nut components of the HeartMate 3 Outflow Graft (HM3 OFG) assembly
Current openFDA PMA Record#
- Device
- HeartMate 3™ Left Ventricular Assist System (LVAS)
- Applicant
- ABBOTT MEDICAL
- PMA number
- P160054
- Supplement
- S130
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2026-07-30
- Decision code
- OK30
- Date received
- 2026-07-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- the addition of an alternate supplier for the Graft Nut and Locking Nut components of the HeartMate 3 Outflow Graft (HM3 OFG) assembly