LIFE PULSE HIGH FREQUENCY VENTILATOR ENDOTRACHEAL TUBE ADAPTER
FDA premarket approval P850064/S012 · decided 1997-05-16
Approval details
- PMA number
- P850064
- Supplement
- S012
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- LIFE PULSE HIGH FREQUENCY VENTILATOR ENDOTRACHEAL TUBE ADAPTER
- Generic name
- VENTILATOR, HIGH FREQUENCY
- Applicant
- Bunnell, Inc.
- Date received
- 1997-04-11
- Decision date
- 1997-05-16
- Days to decision
- 35 days
- Decision code
- APPR
- Product code
- LSZ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Salt Lake City, UT
- Statement
- APPROVAL FOR A LABELING CHANGE TO INCLUDE AN ADDITIONAL WARNING ADVISING AGAINST TROUBLESHOOTING WHILE THE VENTILATOR IS IN OPERATION.
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