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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.
 
DeviceOPTACRYL 60 - CLEAR
Generic NameLens, contact (other material) - daily
Regulation Number886.5916
ApplicantParagon Vision Sciences
947 E. Impala Ave.
Mesa, AZ 85204
PMA NumberP820056
Supplement NumberS037
Date Received04/06/1988
Decision Date10/03/1988
Product Code HQD 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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