|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.|
|Classification Name||lenses, soft contact, extended wear|
|Generic Name||lenses, soft contact, extended wear|
|Supplement Type||real-time process|
|Supplement Reason|| labeling change - indications/instructions/shelf life/tradename|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a ten (10) year expiration date for the permalens (perfilcon a) hydrophilic contact lenses. The device, as modified, will be marketed under the trade name as referenced above with no change in the current indications.