HeartMate II Left Ventricular Assist System (LVAS)
FDA premarket approval P060040/S082 · decided 2022-01-12
Approval details
- PMA number
- P060040
- Supplement
- S082
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- HeartMate II Left Ventricular Assist System (LVAS)
- Generic name
- Ventricular (assist) bypass
- Applicant
- ABBOTT MEDICAL
- Date received
- 2021-12-14
- Decision date
- 2022-01-12
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- Approval for addendums to Instructions for Use and Patient Handbook for HeartMate 3 Left Ventricular Assist System (LVAS) and HeartMate II Left Ventricular Assist System (LVAS)
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510(k) clearances by this applicant
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|---|---|---|
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| Armada™ 14 NC PTA Catheter (K252512) | ABBOTT MEDICAL | 2026-02-13 |
| Assert-IQ (DM5100) (K253516) | ABBOTT MEDICAL | 2025-12-18 |