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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.
 
DeviceENDOTRACHEAL TUBE CHANGER
Generic NameChanger, tube, endotracheal
Regulation Number868.5730
ApplicantInstrumentation Industries, Inc.
1211 St.S Run Rd.
Pittsburg, PA 15236
PMA NumberP800068
Supplement NumberS001
Date Received06/02/1998
Decision Date07/23/1999
Reclassified Date12/09/2004
Product Code LNZ 
Advisory Committee Anesthesiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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.
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