HeartMate 3 Left Ventricular Assist System (LVAS)
FDA premarket approval P160054/S012 · decided 2018-09-12
Approval details
- PMA number
- P160054
- Supplement
- S012
- Supplement type
- Normal 180 Day Track
- 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
- 2018-08-31
- Decision date
- 2018-09-12
- Days to decision
- 12 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- Approval for the addition of an Intensive Care Unit (ICU) Cover accessory.
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