Life Pulse High Frequency Ventilator
FDA premarket approval P850064/S045 · decided 2021-10-13
Approval details
- PMA number
- P850064
- Supplement
- S045
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Life Pulse High Frequency Ventilator
- Generic name
- VENTILATOR, HIGH FREQUENCY
- Applicant
- Bunnell, Inc.
- Date received
- 2021-02-16
- Decision date
- 2021-10-13
- Days to decision
- 239 days
- Decision code
- APPR
- Product code
- LSZ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Salt Lake City, UT
- Statement
- Approval for a change to the manufacturing process of cutting the heater wire, including the process of stripping the ends of the cut heater wire. It is proposed that an approved vendor perform the requested tasks.
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