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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameMODELS GL65C-OUV ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)
Classification Nameintraocular lens
Generic Namemodified j-loop posterior chamber iol
Regulation Number886.3600
ApplicantMEDICAL DEVELOPMENT RESEARCH, INC.
PMA NumberP880072
Supplement NumberS040
Date Received12/05/1995
Decision Date04/17/1996
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for models gl65c-ouv and ps50d-ouv as tier a modifications of previously approved medical developmental reasearch, inc. Parent iols.
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