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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 NamePC-IOL
Classification Nameintraocular lens
Generic Nameuv-absorbing posterior chamber intraocular lenses
Regulation Number886.3600
ApplicantOPHTHALMIC INNOVATIONS INTL., INC.
PMA NumberP970034
Supplement NumberS007
Date Received07/06/2000
Decision Date01/17/2001
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a new manufacturing facility located at ophthalmic innovations international, inc. , ontario, california.
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