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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 NameOCUCOAT
Classification Nameaid, surgical, viscoelastic
Regulation Number886.4275
ApplicantBAUSCH & LOMB, INC.
PMA NumberP860047
Supplement NumberS019
Date Received01/24/2006
Decision Date12/21/2006
Product Code
LZP
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track no user fee
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located at 8500 hidden river parkway, tampa, florida.
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