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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.
 
DeviceBAUSCH AND LOMB POLYMACON CONTACT LENSES
Generic NameLenses, soft contact, extended wear
ApplicantBausch & Lomb, Inc.
1400 NORTH GOODMAN ST.
ROCHESTER, NY 14609-3547
PMA NumberN16895
Supplement NumberS086
Date Received10/26/1999
Decision Date11/02/1999
Product Codes LPL 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 introduction of a manufacturing process change for the Polymacon Contact Lenses for extended wear. The requested change will allow the lenses to be manufactured using an alternate polyvinyl chloride resin mold material. The manufacturing process and procedures will not change.
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