FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Ventricular (Assist) Bypass
PMA: P060040
·
Supplement: S122
·
Decision Dec 17, 2025
Classifications
1
FEI Numbers
0
Registration Numbers
0
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Basic Information
- Device Name
- Ventricular (Assist) Bypass
- Trade Name
- HeartMate II Left Ventricular Assist System
- PMA Number
- P060040
- Supplement Number
- S122
- 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
- December 17, 2025
- Date Received
- November 20, 2025
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Alternate MOSFET and capacitor components in the Power Supply Printed Circuit Board Assembly (PCBA) of the Universal Battery Charger (UBC)
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 |