FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Ventricular (Assist) Bypass
PMA: P100047
·
Supplement: S236
·
Decision Feb 3, 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
- S236
- Device Class
- FDA Class 3
- Product Code
- DSQ
- Generic Name
- Ventricular (assist) bypass
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- February 3, 2026
- Date Received
- January 5, 2026
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
changes related to upgrades of the HVAD Battery Packtesters
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 |