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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 NameSOFLEX UV-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENS MODELS L15IU AND L16IU
Classification Nameintraocular lens
Generic Nameposterior chamber intraocular lenses
Regulation Number886.3600
ApplicantBAUSCH & LOMB SURGICAL, INC.
PMA NumberP910061
Supplement NumberS004
Date Received09/18/1998
Decision Date10/02/1998
Product Code
HQL
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason change design/components/specifications - specifications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change in the raw material specifications for soflex iols.
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