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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.
 
DeviceNOVALENS (ROSILFOCON A)
Generic NameLens, contact (other material) - daily
Regulation Number886.5916
ApplicantOcutec Corporation, Inc.
2700-200 Gateway Center Blvd.
Morrisville, NC 27560
PMA NumberP890058
Supplement NumberS010
Date Received10/16/1992
Decision Date09/02/1993
Product Code HQD 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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