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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.
 
Trade NameOCUFILCON D SPHERICAL AND TORIC EXTENDED WEAR CONTACT LENSES
Classification Namelenses, soft contact, extended wear
Generic Namecontact lens
Regulation Number886.5925
ApplicantOCULAR SCIENCES PUERTO RICO, INC.
PMA NumberP890023
Supplement NumberS004
Date Received10/02/1995
Decision Date08/28/1996
Product Code
LPM[ Registered Establishments with LPM ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the following: 1)modifying the manufacturing process for the ocufilcon d spherical and toric extended wear lenses from a locator tint dipping process at the end of the manufacturing procedure to the addition of an in-monomer tint incorporating vat blue 6 dye during the polymerization phase of the manufacturing process; 2)using blister packaginas alternate packaging material; and 3)adding the following alternate manufactuiring site for lenses manufactured by the process described in item 1: ocular sciences/american hydron, chandlers ford industrial estate, chandlers ford, eastleigh, hampshire s053 4 nd, england.
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