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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantBausch & Lomb, Inc.
1400 North Goodman Street
Rochester, NY 14609
PMA NumberP800016
Date Received04/15/1980
Decision Date03/26/1982
Withdrawal Date 11/26/2008
Product Code HQL 
Notice Date 04/20/1992
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination ProductNo
Supplements: S001 S003 S005 S006 S007 S011 S012 S013 S014