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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 REWETTING DROPS
Generic NameAccessories, soft lens products
Regulation Number886.5928
ApplicantAlcon Laboratories
R
Van Nuys, CA 30348
PMA NumberP830034
Supplement NumberS031
Date Received12/23/1996
Decision Date03/26/1997
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 REDUCING THE FILL VOLUME OF OPTI-FREE(R) REWETTING DROPS FROM THE CURRENTLY APPROVED 5 ML TO 3 ML IN THE SAME OPAQUE LOW DENSITY POLYETHYLENE (LDPE) BOTTLE.
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