HeartMate II Left Ventricular Assist System (LVAS)
FDA premarket approval P060040/S076 · decided 2020-06-26
Approval details
- PMA number
- P060040
- Supplement
- S076
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- HeartMate II Left Ventricular Assist System (LVAS)
- Generic name
- Ventricular (assist) bypass
- Applicant
- ABBOTT MEDICAL
- Date received
- 2020-01-28
- Decision date
- 2020-06-26
- Days to decision
- 150 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- Approval for an alternate 3rd Tier yarn supplier to manufacture the vascular graft components for the HeartMate II and HeartMate 3 Left Ventricular Assist Systems (LVAS).
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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 |