HeartMate 3 Left Ventricular Assist System
ABBOTT MEDICAL · Ventricular (assist) bypass · Cardiovascular
Open FDA's page for this record- PMA number
- P160054
- Supplement number
- S136
- Applicant
- ABBOTT MEDICAL
- Street 1
- 6035 Stoneridge Dr.
- City
- Pleasanton
- State
- CA
- Zip
- 94588
- Generic name
- Ventricular (assist) bypass
- Trade name
- HeartMate 3 Left Ventricular Assist System
- Product code
- DSQ
- Advisory committee
- CV
- Advisory committee description
- Cardiovascular
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited review flag
- N
- Date received
- 2026-09-21
- Decision date
- 2026-10-19
- Decision code
- OK30
- Ao statement
- updated manufacturing inspection acceptance criteria for the modular cable ends
- Harmonized identifiers (openFDA)
- Device name
- Ventricular (Assist) Bypass
- Medical specialty description
- Unknown
- Device class
- 3
- Registration number
- 2916596, 3005228872, 3011823740, 2528981, 3019807891, 2031044, 3008792657, 3003306248, 3002807090, 1927395, 1218444, 3010163695, 3012931014, 2134470, 1319639, 2182208, 9612515, 3004582654, 3007042319, 2133810, 2029275, 1721676, 3008454189
- FEI number
- 2916596, 3005228872, 3011823740, 2528981, 3019807891, 3002462840, 3002808437, 3001236763, 1000306431, 3008792657, 3003306248, 1927395, 1218444, 3010163695, 3012931014, 3000203066, 2182208, 3006003617, 3004582654, 3007042319, 1000138054, 1721676, 3008454189