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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Namechanger, tube, endotracheal
Generic Nameendotracheal tube changer
Regulation Number868.5730
PMA NumberP800068
Supplement NumberS001
Date Received06/02/1998
Decision Date07/23/1999
Product Code
LNZ[ Registered Establishments with LNZ ]
Advisory Committee Anesthesiology
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the following changes: 1)changes in manufacturing: a) new vendor for lumen extrusion; b) new vendor for imprinting the ink (reacted with a hardener) onto the tube changer; and c) eight additional sizes and three additional colors. 2) change in labeling: a) change in the indications for use statement to reflect the eight new models; and b) revisions in the instructions for use.