HeartMate 3 Left Ventricular Assist System
FDA premarket approval P160054/S039 · decided 2022-03-24
Approval details
- PMA number
- P160054
- Supplement
- S039
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- HeartMate 3 Left Ventricular Assist System
- Generic name
- Ventricular (assist) bypass
- Applicant
- ABBOTT MEDICAL
- Date received
- 2021-09-27
- Decision date
- 2022-03-24
- Days to decision
- 178 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- Approval for various updates to the Instructions for Use to add the final clinical results of the Long-Term Durability Cohort of the pivotal trial and of the post-approval study entitled "Continued Follow-up of the Continued Access Cohort."
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