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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.
 
DeviceCOMFORTCARE GP(R) WETTING AND SOAKING SOLUTION
Generic NameAccessories, soft lens products
Regulation Number886.5928
ApplicantADVANCED MEDICAL OPTICS, INC.
2525 DUPONT DR.
IRVINE, CA 92612
PMA NumberP820053
Supplement NumberS025
Date Received01/17/1997
Decision Date02/13/1997
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 ALLERGAN, 8301 MARS DR., WACO, TX 76712 AS AN ALTERNATE MANUFACTURING SITE
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