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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceMODELS GL65C-OUV ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantEyekon Medical, Inc.
2451 Enterprise Rd.
Clearwater, FL 33763
PMA NumberP880072
Supplement NumberS040
Date Received12/05/1995
Decision Date04/17/1996
Product Code HQL 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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