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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.
 
DeviceSTYLE UV40 POSTERIOR CHAMBER LENS
Classification Nameintraocular lens
Generic Nameintraocular lens
Regulation Number886.3600
Applicant
CARL ZEISS MEDITEC AG
5160 hacienda drive
dublin, CA 94568
PMA NumberP830056
Supplement NumberS041
Date Received08/25/1988
Decision Date01/26/1989
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
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