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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 NameBAUSCH & LOMB SOFLENS (POLYMACON) CONTACT LENS
Classification Namelenses, soft contact, extended wear
Generic Namepolymacon contact lenses
Regulation Number886.5925
ApplicantBAUSCH & LOMB, INC.
PMA NumberN16895
Supplement NumberS091
Date Received11/12/2008
Decision Date05/05/2009
Product Code
LPM[ Registered Establishments with LPM ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason change design/components/specifications - material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the use of an alternate resin sunoco d-115a to form the blister package container for the device.
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