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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.
 
DeviceLL-79 LIDOFILCON B (HYDROPHILIC) CONTACT LENS
Generic NameLenses, soft contact, extended wear
Regulation Number886.5925
ApplicantLOMBART LENSES, LTD.
1215 BOISSEVAIN AVE.
NORFOLK, VA 23507
PMA NumberP840031
Supplement NumberS009
Date Received06/25/1998
Decision Date07/09/1998
Withdrawal Date 11/07/2007
Product Code LPM 
Advisory Committee Ophthalmic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
The 30-day Notice requested that the device, which is terminally sterilized by steam sterilization, be released into distribution using parametric criteria rather than the existing Biological Indicators.
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