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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 NumberS008
Date Received07/11/1996
Decision Date09/05/1996
Product Code LPN 
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A CHANGE IN THE STERILIZING FILTER (0.22 MICRON)
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