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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.
 
DeviceZIRCONIA SILICATE BEAD IOL TUMBLE POLISHING
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantALCON
6201 South Freeway
Fort Worth, TX 76134-2099
PMA NumberP820035
Supplement NumberS012
Date Received08/21/1991
Decision Date12/20/1991
Withdrawal Date 12/30/1999
Product Code HQL 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
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