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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
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantALCONRESEARCH,LTD.
6201 SOUTH FREEWAY
FORT WORTH,, TX 76134
PMA NumberP830040
Supplement NumberS024
Date Received01/31/1995
Decision Date07/24/1995
Withdrawal Date 06/23/2010
Product Code HQL 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE REDUCTION IN BIOLOGICAL INDICATOR INCUBATION TIME FROM 7 TO 5 DAYS
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