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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.
 
DevicePOSTERIOR CHAMBER INTRAOCULAR LENSES STYLE 38XE
Classification Nameintraocular lens
Generic Nameintraocular lens
Regulation Number886.3600
Applicant
ALCONRESEARCH,LTD.
6201 south freeway
fort worth,, TX 76134
PMA NumberP830040
Supplement NumberS018
Date Received03/12/1991
Decision Date09/23/1991
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
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