LifePulse High Frequency Ventilator
FDA premarket approval P850064/S051 · decided 2023-12-28
Approval details
- PMA number
- P850064
- Supplement
- S051
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LifePulse High Frequency Ventilator
- Generic name
- VENTILATOR, HIGH FREQUENCY
- Applicant
- Bunnell, Inc.
- Date received
- 2023-05-31
- Decision date
- 2023-12-28
- Days to decision
- 211 days
- Decision code
- APPR
- Product code
- LSZ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Salt Lake City, UT
- Statement
- approval for a change in the formulation of the resin material for the LifePort Adapter.
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