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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.
 
DeviceTIER A MODELS 24050,24150,25050,25350-125 LENSES
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantEyetech, LLC
7016 6th St. N.
Oakdale, MN 55128
PMA NumberP880082
Supplement NumberS012
Date Received05/01/1991
Decision Date09/04/1991
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
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