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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameTENNANT(TM) & KELMAN(TM) TYPE II
Classification Nameintraocular lens
Generic Nameintraocular lens, anterior chamber
Regulation Number886.3600
ApplicantBAUSCH & LOMB, INC.
PMA NumberP800016
Date Received04/15/1980
Decision Date03/26/1982
Withdrawal Date 11/26/2008
Product Code
HQL[ Registered Establishments with HQL ]
Notice Date 04/20/1992
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination Product No
Supplements: S001 S003 S005 S006 S007 S011 
S012 S013 S014 S015 
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