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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.
 
DeviceSOFT MATE(R) CONSEPT R-2 NEUTRALIZING & RINSING
Generic NameAccessories, soft lens products
Regulation Number886.5928
ApplicantADVANCED MEDICAL OPTICS, INC.
2525 DUPONT DR.
IRVINE, CA 92612
PMA NumberP840066
Supplement NumberS023
Date Received02/07/1990
Decision Date08/15/1990
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
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