PMA P800068S001

Device: ENDOTRACHEAL TUBE CHANGER
Applicant: Instrumentation Industries, Inc.
PMA number: P800068
Supplement: S001
Product code: LNZ
Decision date: 1999-07-23
Generic name: Changer, tube, endotracheal
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.

Current openFDA PMA Record#

Device: ENDOTRACHEAL TUBE CHANGER
Applicant: Instrumentation Industries, Inc.
PMA number: P800068
Supplement: S001
Product code: LNZ
Generic name: Changer, tube, endotracheal
Decision date: 1999-07-23
Decision code: APPR
Date received: 1998-06-02
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
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.