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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
Classification Namechanger, tube, endotracheal
Generic Namechanger, tube, endotracheal
Regulation Number868.5730
1211 streets run rd.
pittsburg, PA 15236
PMA NumberP800068
Date Received11/21/1980
Decision Date07/21/1981
Reclassified Date 12/09/2004
Product Code
LNZ[ Registered Establishments with LNZ ]
Notice Date 08/14/1981
Advisory Committee Anesthesiology
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002