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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceLIFE PULSE HIGH FREQUENCY VENTILATOR ENDOTRACHEAL TUBE ADAPTER
Classification Nameventilator, high frequency
Generic Nameventilator, high frequency
Applicant
BUNNELL, INC.
436 lawndale dr.
salt lake city, UT 84115
PMA NumberP850064
Supplement NumberS014
Date Received08/28/1998
Decision Date09/16/1998
Product Code
LSZ[ Registered Establishments with LSZ ]
Advisory Committee Anesthesiology
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of a caution to the labeling.
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