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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.
 
DeviceMENTOR POSTERIOR CHAMBER INTRAOCULAR UV ABSORBING PMMA LENSES
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantCarl Zeiss Meditec, AG
5160 Hacienda Dr.
Dublin, CA 94568
PMA NumberP830056
Supplement NumberS079
Date Received11/12/1998
Decision Date05/11/1999
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
Approval Order Statement  
Approval for posterior chamber intraocular lens models C451F, C421F, and C455A5. These lenses are intended to be used for primary implantation for the visual correction of aphakia in patients 60 years of age or older where a cataractous lens has been removed using extracapsular extraction methods. The lenses are intended to be placed in either the ciliary sulcus or capsular bag.
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