FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Ventilator, High Frequency
PMA: P850064
·
Supplement: S058
·
Decision May 7, 2026
Classifications
1
FEI Numbers
0
Registration Numbers
0
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Basic Information
- Device Name
- Ventilator, High Frequency
- Trade Name
- LifePulse High Frequency Ventilator (LifePulse HFV) Model 204
- PMA Number
- P850064
- Supplement Number
- S058
- Device Class
- FDA Class 3
- Product Code
- LSZ
- Generic Name
- VENTILATOR, HIGH FREQUENCY
- Medical Specialty
- Unknown
- Advisory Committee
- Anesthesiology
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- May 7, 2026
- Date Received
- April 13, 2026
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
This is a 30-DN to provide the change in power cord testing as a result of a CAPA investigation into a miswiring of one single power cord. the testing is adequate to test the incoming inspection for cross-wired power cords and not as a complete safety check.
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 |
|---|---|---|---|
| LSZ | Ventilator, High Frequency | FDA class 3 | Unknown |