FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Ventricular (Assist) Bypass
PMA: P160054
·
Supplement: S121
·
Decision May 29, 2026
Classifications
1
FEI Numbers
0
Registration Numbers
0
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Basic Information
- Device Name
- Ventricular (Assist) Bypass
- Trade Name
- HeartMate 3 Left Ventricular Assist System
- PMA Number
- P160054
- Supplement Number
- S121
- Device Class
- FDA Class 3
- Product Code
- DSQ
- Generic Name
- Ventricular (assist) bypass
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- May 29, 2026
- Date Received
- February 9, 2026
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
Approval for a change of material of the contacts on the PCBA and Ribbon Cable Connector interface of the 11 Volt Backup Battery of the HeartMate II (HMII) and HeartMate 3 (HM3) System Controllers
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DSQ | Ventricular (Assist) Bypass | FDA class 3 | Unknown |