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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
Device3M VISION CARE POSTERIOR CHAMBER IOL,PERSPEX CQ-UV
Classification Nameintraocular lens
Generic Nameintraocular lens
Regulation Number886.3600
Applicant
ALCONRESEARCH,LTD.
6201 south freeway
fort worth,, TX 76134
PMA NumberP830040
Supplement NumberS025
Date Received08/09/1995
Decision Date12/13/1995
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR AN ALTERNATE STERILIZATION PROCESS INCLUDING AERATION TIME AND THE ESTABLISHMENT OF THE BIOLOGICAL INDICATOR INCUBATION TIME
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