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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NamePUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENS
Classification Namelenses, soft contact, extended wear
Generic Namebalafilcon a visibility tinted contact lens
Regulation Number886.5925
ApplicantBAUSCH & LOMB, INC.
PMA NumberP980006
Supplement NumberS005
Date Received01/06/2004
Decision Date02/11/2004
Product Code
LPM[ Registered Establishments with LPM ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track no user fee
Supplement Reason postapproval protocol or modification to a protocol
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to modify the post-approval study for the device.
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