HeartMate 3 Left Ventricular Assist System (LVAS)
FDA premarket approval P160054/S050 · decided 2023-01-10
Approval details
- PMA number
- P160054
- Supplement
- S050
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- HeartMate 3 Left Ventricular Assist System (LVAS)
- Generic name
- Ventricular (assist) bypass
- Applicant
- ABBOTT MEDICAL
- Date received
- 2022-10-31
- Decision date
- 2023-01-10
- Days to decision
- 71 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- Approval for a software update to the HeartMate Touch Communication (HM Touch) Application software to fix two anomalies and add eleven new language translations.
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