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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) PRESERVED SALINE SOL.SPEC CHANGE
Generic NameAccessories, soft lens products
Regulation Number886.5928
ApplicantAdvanced Medical Optics, Inc.
2525 Dupont Dr.
Irvine, CA 92612
PMA NumberN18020
Supplement NumberS040
Date Received05/30/1995
Decision Date09/20/1995
Product Code LPN 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A REVISED PACKAGE INSERT TEXT WHICH IS TO BE PRINTED ON THE 8 FL. OZ AND 15 FL. OZ. AEROSOL CANS OF THE REFERENCED DEVICE AND THE ELIMINATION OF THE PACKAGE INSERT FOR THESE SIZE CONTAINERS
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