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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.
 
DevicePOSTERIOR CHAMBER IOL'S
Classification Nameintraocular lens
Generic Nameintraocular lens
Regulation Number886.3600
Applicant
AAREN SCIENTIFIC
4290 east brickell st, bldg a
ontario, CA 91761
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 report
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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