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Prosthesis, Tracheal, Expandable, Polymeric

FDA product code NYT · 3 cleared devices

Class 2 General, Plastic Surgery
Regulation
21 CFR 878.3720
Review panel
SU
Implant
Yes
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
1995-10-13 – 2001-11-27

The device is intended to provide support to weakened or constricting airway walls and indicated for the treatment of tracheobronchial strictures produced by malignant neoplasms or in benign strictures, after all alternative therapies have been exhausted.

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