|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||HYDRASOFT, HYDRASOFT TORIC, HYDRASOFT XW AND HYDRASOFT TORIC XW (METHALICON B) SOFT (HYDROPHILIC) CONTACT LENSES|
|Classification Name||lenses, soft contact, daily wear|
|Supplement Type||normal 180 day track|
|Supplement Reason|| labeling change - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for reformatting the package insert, professional fitting and information guide, and patient instructions. The modified labeling does not result in changes in the indications for use for the devices.