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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.
 
DeviceUNPRESERVED CONSEPT-2 RINSING & NEUTRALIZING SOL.
Generic NameAccessories, soft lens products
Regulation Number886.5928
ApplicantAdvanced Medical Optics, Inc.
2525 Dupont Dr.
Irvine, CA 92612
PMA NumberP840066
Supplement NumberS029
Date Received10/03/1991
Decision Date02/29/1996
Product Code LPN 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE UNPRESERVED FORMULATION OF CONSEPT-2 NEUTRALIZING AND RINSING SOLUTION TO BE PACKAGED IN A NON-AEROSOL MULTI-DOSE 8 AND 12 FLUID PZ CONTAINERS WITH A FILTER/VALVE CLOSURE SYSTEM LABELED WITH A DISCARD DATE OF 60 DAYS
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