510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
OOYClass III

Bronchial Thermoplasty System

Unknown
FDA source (opens on fda.gov)

OOY is the FDA product code for Bronchial Thermoplasty System, a class III device type. FDA's definition for this code reads: "Bronchial thermoplasty systems are intended for the treatment of severe persistent asthma in patients whose asthma is not well controlled with inhaled corticosteroids and long acting beta agonists to reduce the effects of their asthma by using thermal radiofrequency energy to ablate smooth muscle tissue in the...". As of , FDA records hold no 510(k) clearances under this code and one recall.

Classification record

Product code
OOY
Device name
Bronchial Thermoplasty System
FDA definition
Bronchial thermoplasty systems are intended for the treatment of severe persistent asthma in patients whose asthma is not well controlled with inhaled corticosteroids and long acting beta agonists to reduce the effects of their asthma by using thermal radiofrequency energy to ablate smooth muscle tissue in the patient's airways.
Device class
Class III
Review panel
Unknown
Submission type
PMA
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
1

Companies listing this code with FDA

Companies whose registered establishments list this code