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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.
 
DeviceSTYLE UV40 POSTERIOR CHAMBER LENS
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantCarl Zeiss Meditec, AG
5160 Hacienda Dr.
Dublin, CA 94568
PMA NumberP830056
Supplement NumberS042
Date Received09/13/1988
Decision Date08/18/1989
Withdrawal Date10/12/2006
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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