FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Ventricular (Assist) Bypass
PMA: P100047
·
Supplement: S235
·
Decision Apr 7, 2026
Classifications
1
FEI Numbers
0
Registration Numbers
0
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Basic Information
- Device Name
- Ventricular (Assist) Bypass
- Trade Name
- HeartWare HVAD System
- PMA Number
- P100047
- Supplement Number
- S235
- 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
- April 7, 2026
- Date Received
- November 21, 2025
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
Approval for changes to the HVAD Battery Pack including: 1) adjusting the State of Charge (SOC) to no greater than 30%, 2) enabling the Sleep Mode feature before packaging and shipping, 3) adding a new ICAO Packing Instruction (PI) 966 for UN3481, 4) adding a Sleep Mode Battery Charger/Discharger as a new manufacturing process equipment, and 5) discontinuing the HVAD Batteries recharge process.
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 |