FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Ventilator, High Frequency
PMA: P850064
·
Supplement: S014
·
Decision Sep 16, 1998
Classifications
1
FEI Numbers
5
Registration Numbers
5
Basic Information
- Device Name
- Ventilator, High Frequency
- Trade Name
- LIFE PULSE HIGH FREQUENCY VENTILATOR ENDOTRACHEAL TUBE ADAPTER
- PMA Number
- P850064
- Supplement Number
- S014
- Device Class
- FDA Class 3
- Product Code
- LSZ
- Generic Name
- VENTILATOR, HIGH FREQUENCY
- Medical Specialty
- Unknown
- Advisory Committee
- Anesthesiology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- September 16, 1998
- Date Received
- August 28, 1998
- Supplement Type
- Special (Immediate Track)
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
Approval for the addition of a caution to the labeling.
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 |