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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.
 
DeviceSOFLEX UV ABSORBING SILICONE POSTERIOR INTRAOCULAR LENSES
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantBAUSCH & LOMB
50 Technology Drive
Irvine, CA 92618
PMA NumberP910061
Supplement NumberS007
Date Received12/18/1998
Decision Date03/08/1999
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
Approval Order Statement  
Approval for a manufacturing qualification protocol and a manufacturing site located at 21 Park Place Blvd., N., Clearwater, FL 33759.
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