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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.
 
DeviceSM-1, CR-1, & GR-1 IOLS
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantAlcon Laboratories
6201 S. Fwy.
Fort Worth, TX 76134
PMA NumberP840060
Date Received11/14/1984
Decision Date04/30/1986
Product Code HQL 
Docket Number 86M-0232
Notice Date 06/11/1986
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Supplements: S037 S027 S001 S002 S003 S004 S005 S006 S007 S008 S010 S011 
S012 S014 S017 S018 S019 S022 S023 S026 S024 S025  S029 
S039 S028 S030 S044 S035 S036 S033 S034 S043 S042 S047 S048 
S050 S051 S045 S046 S032 S038 S041 S031 S040 S049 
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