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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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 Namelenses, soft contact, daily wear
Generic Namecontact lens
Regulation Number886.5925
PMA NumberP940013
Supplement NumberS005
Date Received04/04/1996
Decision Date10/07/1996
Product Code
LPL[ Registered Establishments with LPL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - color additive
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the tinting of the device with an alternate, non-reactive, light blue-green locator tint (d&c green no. 6, c. I. No. 61565) using an in-monomer tinting process for the precision(tm) un (vasurfilcon a) hydrophilic contact lens for extended wear.