HeartMate 3 Left Ventricular Assist System
FDA premarket approval P160054/S008 · decided 2018-10-18
Approval details
- PMA number
- P160054
- Supplement
- S008
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- HeartMate 3 Left Ventricular Assist System
- Generic name
- Ventricular (assist) bypass
- Applicant
- ABBOTT MEDICAL
- Date received
- 2018-05-03
- Decision date
- 2018-10-18
- Days to decision
- 168 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- Approval for the HeartMate 3 Left Ventricular Assist System. The device is indicated for providing short- and long-term mechanical circulatory support (e.g., as bridge to transplant or myocardial recovery, or destination therapy) in patients with advanced refractory left ventricular heart failure.
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