HeartMate 3 Left Ventricular Assist System (LVAS)
FDA premarket approval P160054/S005 · decided 2018-08-24
Approval details
- PMA number
- P160054
- Supplement
- S005
- 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
- 2018-03-16
- Decision date
- 2018-08-24
- Days to decision
- 161 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- Approval for the addition of the Surgical Enhancement Tools, including the Mini Apical Cuff, the Coring Tool, and the Apical Cuff Holder.
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510(k) clearances by this applicant
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|---|---|---|
| EnSite™ X EP System (K262006) | Abbott Medical | 2026-07-15 |
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| Disposable Radiofrequency Cannula (K253907) | ABBOTT MEDICAL | 2026-04-16 |
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| Armada™ 14 NC PTA Catheter (K252512) | ABBOTT MEDICAL | 2026-02-13 |
| Assert-IQ (DM5100) (K253516) | ABBOTT MEDICAL | 2025-12-18 |