LifePulse High Frequency Ventilator
FDA premarket approval P850064/S039 · decided 2019-06-14
Approval details
- PMA number
- P850064
- Supplement
- S039
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- LifePulse High Frequency Ventilator
- Generic name
- VENTILATOR, HIGH FREQUENCY
- Applicant
- Bunnell, Inc.
- Date received
- 2019-02-27
- Decision date
- 2019-06-14
- Days to decision
- 107 days
- Decision code
- APPR
- Product code
- LSZ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Salt Lake City, UT
- Statement
- Approval for the manufacturer of the injection molded parts including the Patient Circuit Cartridge halves, Cartridge Back and Cartridge Front, and the LifePort Adapters Patient End and Machine End, all sizes.
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