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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.
 
DeviceALLERGAN(R) REWETTING DROPS
Generic NameAccessories, soft lens products
Regulation Number886.5928
ApplicantADVANCED MEDICAL OPTICS, INC.
2525 DUPONT DR.
IRVINE, CA 92612
PMA NumberP910075
Supplement NumberS006
Date Received06/08/1995
Decision Date02/23/1996
Product Code LPN 
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 STERI-TECH, INC., P.O. BOX 1145, SALINAS, PUERTO RICO 00751 AS AN ALTERNATE CONTRACT STERILIZATION SITE, AND FOR THE USE OF 100% ETHYLENE OXIDE TO STERILIZE PLASTIC BOTTLES, TIPS, AND CAPS USED IN THE MANUFACTURE OF THE DEVICE
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