LifePulse High Frequency Ventilator
FDA premarket approval P850064/S054 · decided 2024-09-19
Approval details
- PMA number
- P850064
- Supplement
- S054
- Supplement type
- 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
- 2024-08-26
- Decision date
- 2024-09-19
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- LSZ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Salt Lake City, UT
- Statement
- The sponsor has adequately addressed all concerns relating to the manufacturing procedure and equipment revisions implicated in this 30-day notice.
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