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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.
 
DeviceOPTI-FREE(R) RINSING, DISINFECTING, & STORAGE SOLUTION OPTI-FREE(R) EXPRESS(TM) MULTI-PURPOSE SOLUTION
Generic NameAccessories, soft lens products
Regulation Number886.5928
ApplicantAlcon Laboratories
R
Van Nuys, CA 30348
PMA NumberP830034
Supplement NumberS033
Date Received03/04/1997
Decision Date03/19/1997
Product Code LPN 
Advisory Committee Ophthalmic
Supplement TypeSpecial (Immediate 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 MODIFICATION IN THE PACKAGE INSERT TO INCLUDE ADDITION OF THE FOLLOWING STATEMENT IN THE DIRECTIONS SECTIONS: "YOU MAY STORE YOUR LENSES IN THE UNOPENED CASE UNTIL READY TO WEAR, UP TO A MAXIMUM OF THIRTY DAYS. IF YOUR LENSES ARE STORED FOR LONGER PERIODS OF TIME, THEY MUST BE CLEANED AND DISINFECTED WITH FRESH SOLUTION EVERY THIRTY DAYS AND PRIOR TO WEAR."
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