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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.
 
DeviceSOFLENS (POLYMACON) CONTACT LENSES
Generic NameLenses, soft contact, extended wear
ApplicantBausch & Lomb, Inc.
1400 N. Goodman St.
Rochester, NY 14609
PMA NumberN16895
Supplement NumberS085
Date Received08/07/1997
Decision Date10/15/1997
Product Codes LPL LPM 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day 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 labeling modifications: 1) combination of the separate package insert and professional fitting guide into a single package insert and fitting guide; and 2) incorporation of information in the package insert and fitting guide related to prescribing the lenses for frequent replacement and disposable wear, along with separate patient information booklets for disposable and frequent replacement wear.
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