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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.
 
DeviceSILICONE AND PMMA INTRAOCULAR LENSES AND OCUCOAT
Classification Nameintraocular lens
Generic Nameintraocular lens
Regulation Number886.3600
Applicant
BAUSCH & LOMB
50 technology drive
irvine, CA 92618
PMA NumberP910061
Supplement NumberS011
Date Received03/18/2004
Decision Date06/14/2004
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR THE USE OF A 100% ETHYLENE OXIDE STERILIZATION METHOD IN PRODUCTS IN THEIR FINAL PACKAGED FORM. STERILIZATION WILL OCCUR AT COSMED, INC., LOCATED IN SOUTH PLAINFIELD NEW JERSEY. THE PRODUCTS AFFECTED BY THIS CHANGE ARE THE PMMA AND SILICONE LENSES AND OCUCOAT VISCOADHERENT MANUFACTURED AT BAUSCH & LOMB, INC., CLEARWATER, FLORIDA.
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