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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.
 
DevicePURE VISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENS
Classification Namelenses, soft contact, extended wear
Generic Namelenses, soft contact, extended wear
Regulation Number886.5925
Applicant
Bausch & Lomb, Inc.
1400 north goodman st.
rochester, NY 14609-3547
PMA NumberP980006
Supplement NumberS002
Date Received09/01/1999
Decision Date11/23/1999
Product Code
LPM[ Registered Establishments with LPM ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for: 1) adding a contraindication for the use of Allergan Ultracare disinfecting System to the product labeling (package insert/fitting guide and patient information booklet for frequent replacement wear); 2) removing references to thermal disinfection in the product labeling (package insert and patient information booklets); and 3) adding "The BAUSCH & LOMB(R) PureVision(TM) (balafilcon A) Visibility Tinted Contact Lenses are manufactured by a cast-molding process and are surface treated by the Performa(TM) surface treatment process which transforms hydrophobic silicone to hydrophilic silicate" to the Description section of the package insert/fitting guide.
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