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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.
 
DeviceANTERIOR CHAMBER INTRAOCULAR LENS
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantAlcon
6201 S. Fwy.
Fort Worth, TX 76134
PMA NumberP810001
Supplement NumberS013
Date Received08/08/1996
Decision Date09/04/1998
Withdrawal Date12/30/1999
Product Code HQL 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for an alternate sterilization process using 100% ethylene oxide, an alternate microbiological monitoring system and one resterilization in the event of an "aborted cycle."
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