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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 NamePOSTERIOR CHAMBER IOL'S
Classification Nameintraocular lens
Generic Nameuv-absorbing posterior chamber intraocular lenses
Regulation Number886.3600
ApplicantOPHTHALMIC INNOVATIONS INTL., INC.
PMA NumberP970034
Supplement NumberS009
Date Received04/19/2001
Decision Date06/29/2001
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for ophthalmic innovations international, inc. To private-label its pma-approved posterior-chamber intraocular lenses for distribution in the united states by ciba vision corporation. The devices as modified will be marketed under the trade-names, ciba vision intraocular lens models 0420f, 0455f, 0440u, 0840u, 0430m, 0840z2, and 0840z, and are indicated for the visual correction of aphakia in persons 60 years of age or older, who are undergoing extracapsular extraction and primary lens implantation.
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