LIFE PULSE HIGH FREQUENCY VENTILATOR
FDA premarket approval P850064/S030 · decided 2016-12-23
Approval details
- PMA number
- P850064
- Supplement
- S030
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LIFE PULSE HIGH FREQUENCY VENTILATOR
- Generic name
- VENTILATOR, HIGH FREQUENCY
- Applicant
- Bunnell, Inc.
- Date received
- 2015-03-31
- Decision date
- 2016-12-23
- Days to decision
- 633 days
- Decision code
- APPR
- Product code
- LSZ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Salt Lake City, UT
- Statement
- Approval to add the 3.0 mm ID size LifePort Adapter to the existing product line of LifePort Adapters and adhesive changes to the approved LifePort Adapters.
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