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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 HYDROCARE PRESERVED SALINE SOLUTION, SORBICARE SALINE, AND PRESERVED SALINE
Generic NameAccessories, soft lens products
Regulation Number886.5928
ApplicantADVANCED MEDICAL OPTICS, INC.
2525 DUPONT DR.
IRVINE, CA 92612
PMA NumberN18020
Supplement NumberS039
Date Received05/05/1995
Decision Date04/12/1996
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 ISOTRON IRELAND, LTD. LOCATED AT SRAGH INDUSTRIAL ESTATE, TULLAMORE, CO. OFFALY, IRELAND, AS AN ALTERNATE CONTRACT STERILIZATION SITE,AND FOR THE USE OF 100% ETHYLENE OXIDE TO STERILIZE THE PLASTIC BOTTLES, TIPS, AND CAPS
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