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.
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.
| Device | ENDOTRACHEAL TUBE CHANGER |
| Generic Name | Changer, Tube, Endotracheal |
| Applicant | INSTRUMENTATION INDUSTRIES, INC. |
| Date Received | 1998-06-02 |
| Decision Date | 1999-07-23 |
| PMA | P800068 |
| Supplement | S001 |
| Product Code | LNZ |
| Advisory Committee | Anesthesiology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | INSTRUMENTATION INDUSTRIES, INC. 1211 Streets Run Rd. pittsburg, PA 15236 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P800068 | Original Filing | |
| S002 | 1999-09-03 | Normal 180 Day Track |
| S001 | 1998-06-02 | Normal 180 Day Track |