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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 NameBIOMEDICS 38 (POLYMACON) HYDROPHILIC CONTACT LENSES
Classification Namelenses, soft contact, extended wear
Regulation Number886.5925
ApplicantOCULAR SCIENCES PUERTO RICO, INC.
PMA NumberP780007
Supplement NumberS042
Date Received09/17/1999
Decision Date12/14/1999
Product Code
LPM[ Registered Establishments with LPM ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason express gmp supplement
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a new manufacturing facility located at ocular sciences/american hydron, juana diaz industrial park, 500 road 531, juana diaz, puerto rico.
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