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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceSOFLENS(R) (POLYMACON) P.A.1 SERIES
Classification Namelenses, soft contact, extended wear
Generic Namelenses, soft contact, extended wear
Regulation Number886.5925
Applicant
Bausch & Lomb, Inc.
1400 north goodman st.
rochester, NY 14609-3547
PMA NumberN16895
Supplement NumberS019
Date Received10/19/1981
Decision Date11/16/1982
Product Code
LPM[ Registered Establishments with LPM ]
Notice Date 12/17/1982
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination Product No
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