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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceCOMPLETE BRAND LUBRICATING AND REWETTING DROPS
Generic NameAccessories, soft lens products
Regulation Number886.5928
ApplicantADVANCED MEDICAL OPTICS, INC.
2525 DUPONT DR.
IRVINE, CA 92612
PMA NumberP910075
Supplement NumberS004
Date Received04/06/1995
Decision Date12/05/1995
Product Code LPN 
Docket Number n -
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE FOLLOWING ALTERNATE MANUFACTURING SITE:ALLERGAN AMERICA, PUERTO RICO ROAD 345 KM 1.5, HORMIGUEROS, PUERTO RICO, 00660
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