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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
Classification Nameintraocular lens
Generic Nameintraocular lens
Regulation Number886.3600
Applicant
AAREN SCIENTIFIC
4290 east brickell st, bldg a
ontario, CA 91761
PMA NumberP970034
Supplement NumberS006
Date Received04/19/2000
Decision Date08/31/2000
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
Approval Order Statement 
APPROVAL TO EXTEND THE POWER RANGE FOR YOUR LENSES TO INCLUDE POWERS BETWEEN +3.5 AND -12.0 DIOPTERS (EXCLUDING ZERO DIOPTER) IN 0.5 DIOPTER INCREMENTS.
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