|Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.|
|Trade Name||BIOFINITY XR|
|Classification Name||lenses, soft contact, extended wear|
|Supplement Type||normal 180 day track no user fee|
|Supplement Reason|| labeling change - trade name|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval to add the new brand name biofinity xr.