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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 INTRAOCULAR LENS
Classification Nameintraocular lens
Generic Nameintraocular lenses
Regulation Number886.3600
ApplicantBAUSCH & LOMB SURGICAL, INC.
PMA NumberP790027
Supplement NumberS067
Date Received04/08/2002
Decision Date05/21/2002
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason express gmp supplement
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a new manufacturing facility located at bausch & lomb, inc. Wilmington, massachusetts. The clear compression molded blank pmma material will be manufactured at this facility.
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