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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 NameSILICONE AND PMMA INTRAOCULAR LENSES AND OCUCOAT
Classification Nameaid, surgical, viscoelastic
Regulation Number886.4275
ApplicantBAUSCH & LOMB, INC.
PMA NumberP860047
Supplement NumberS016
Date Received03/18/2004
Decision Date06/14/2004
Product Code
LZP[ Registered Establishments with LZP ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the use of a 100% ethylene oxide sterilization method in products in their final packaged form. Sterilization will occur at cosmed, inc. , located in south plainfield new jersey. The products affected by this change are the pmma and silicone lenses and ocucoat viscoadherent manufactured at bausch & lomb, inc. , clearwater, florida.
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