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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.
 
DevicePOSTERIOR CHAMBER INTROCULAR LENSES
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantCarl Zeiss Meditec, AG
5160 Hacienda Dr.
Dublin, CA 94568
PMA NumberP830056
Supplement NumberS075
Date Received06/17/1994
Decision Date04/02/1996
Withdrawal Date10/12/2006
Product Code HQL 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR MODELS C420P, C540U, C445F, C840U, U240F0, C540MC, U211F, AND U241FO POSTERIOR CHAMBER INTRAOCULAR LENSES AS TIER A MODIFICATIONS OF CLINICALLY STUDIED PARTENT LENSES
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