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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 NamePMMA SINGLE-PIECE ANTERIOR CHAMBER INTRAOCULAR LENSES
Classification Nameintraocular lens
Generic Nameintraocular lens(iol)21 cfr 886.3600/class iii
Regulation Number886.3600
ApplicantALCON LABORATORIES
PMA NumberP880087
Supplement NumberS011
Date Received10/18/2004
Decision Date03/04/2005
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Type135 review track for 30-day notice
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the use of an additional supplier of polymethylmethacrylate (pmma) for the pmma iols.
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