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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 RESEARCH, LTD.
PMA NumberP880087
Supplement NumberS017
Date Received08/10/2010
Decision Date09/09/2010
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Type30-day notice
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Modifications to the sterilant gas distribution and delivery systems.
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