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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 NameMODEL UV65 SERIES ANTERIOR CHAMBER LENSES
Classification Nameintraocular lens
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantPHARMACIA & UPJOHN CO.
PMA NumberP880070
Supplement NumberS008
Date Received06/23/1998
Decision Date07/15/1998
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a new test method and specification for ethylene oxide residuals prior to product release.
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