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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NamePOLYMETHYLMETHA-CRYLATE (PMMA) INTRAOCULAR LENSES (IOLS)
Classification Nameintraocular lens
Regulation Number886.3600
ApplicantBAUSCH & LOMB, INC.
PMA NumberP870073
Supplement NumberS017
Date Received07/15/2003
Decision Date08/13/2003
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to modify the directions for use for all legally marketed iols under the referenced pmas, to indicate the iols for use in adult patients. Previously, the iols were indicated for use in persons 60 years of age or older. These devices, as modified, will be marketed under their approved trade names and are indicated for primary implantation for the visual correction of aphakia in adult patients where a cataractous lens has been removed by extracapsular extraction methods.
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