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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 NameSM-1, CR-1, & GR-1 IOLS
Classification Nameintraocular lens
Generic Namesingle piece posterior chamber iols
Regulation Number886.3600
PMA NumberP840060
Date Received11/14/1984
Decision Date04/30/1986
Product Code
HQL[ Registered Establishments with HQL ]
Docket Number 86M-0232
Notice Date 06/11/1986
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S010 
S011 S012 S014 S017 S018 S019 S022 S023 S024 
S025 S026 S027 S028 S029 S030 S031 S032 S033 
S034 S035 S036 S037 S038 S039 S040 S041