HeartMate 3 Left Ventricular Assist System
FDA premarket approval P160054/S010 · decided 2018-05-18
Approval details
- PMA number
- P160054
- Supplement
- S010
- Supplement type
- Special (Immediate 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
- 2018-05-16
- Decision date
- 2018-05-18
- Days to decision
- 2 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- Approval for an update to the Instructions for Use regarding Outflow Graft twist obstruction.
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