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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 IOL
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantAlcon Laboratories
6201 S. Fwy.
Fort Worth, TX 76134
PMA NumberP840060
Supplement NumberS022
Date Received02/17/1993
Decision Date02/20/1996
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 A NUMBER OF TIER A MODELS. THE MODELS LISTED IN ATTACHMENT 1 ARE INTENDED FOR BOTH CILIARY SULCUS AND CAPSULAR BAG IMPLANTATION; MODELS LX10BD AND MZ40BD ARE INTENDED FOR CAPSULAR BAG IMPLANTATION ONLY
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