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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 NumberS007
Date Received05/23/1996
Decision Date02/02/1998
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason location change: sterilizer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the use of an alternate sterilizer at the manufacturing site in groningen, the netherlands.
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