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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 AND LOMB POLYMACON CONTACT LENSES
Classification Namelenses, soft contact, extended wear
Generic Namesoft contact lens
Regulation Number886.5925
ApplicantBAUSCH & LOMB, INC.
PMA NumberN16895
Supplement NumberS086
Date Received10/26/1999
Decision Date11/02/1999
Product Code
LPM[ Registered Establishments with LPM ]
Advisory Committee Ophthalmic
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
The 30-day notice requested introduction of a manufacturing process change for the polymacon contact lenses for extended wear. The requested change will allow the lenses to be manufactured using an alternate polyvinyl chloride resin mold material. The manufacturing process and procedures will not change.
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