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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.
 
DevicePureVision2 (balafilcon A) Visibility Tinted Soft (hydrophilic) Contact Lenses
Generic NameLenses, soft contact, extended wear
Regulation Number886.5925
ApplicantBausch & Lomb, Inc.
1400 N. Goodman St.
Rochester, NY 14609
PMA NumberP980006
Supplement NumberS031
Date Received10/09/2020
Decision Date11/18/2021
Product Code LPM 
Advisory Committee Ophthalmic
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the replacement of an obsolete dioptric-power measurement system for "in-air" power measurements of the PureVision2® (balafilcon A) Visibility Tinted Soft (hydrophylic) Contact Lenses for Astigmatism.
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