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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 NameMODEL 304 (ULTRA C-LOOP)
Classification Nameintraocular lens
Regulation Number886.3600
PMA NumberP860059
Date Received12/04/1986
Decision Date02/12/1988
Withdrawal Date 07/13/2000
Product Code
HQL[ Registered Establishments with HQL ]
Docket Number 88M-0066
Notice Date 03/28/1988
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S013 S014 S015 S016 S017 S019 S020 
S021 S023 S026 S029 S031 S033 S036 S037 S045 
S046 S048 S049 S050 S051 S053 S054 S056 S058 
S059 S061 S062 S063 S064 S065 S066 S067 S068 
S069 S070 S071 S073 S074 S075 S076 S077