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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.
 
DeviceVISTACRYL 18(KOLFOCON A) 32(KOLFOCON B) RGP LENSES
Generic NameLens, contact (other material) - daily
Regulation Number886.5916
ApplicantVista Optics, Ltd.
10-12 Larkstore Park, Lodge
Rd.,
Staplehurst, Kent TN 12 OQV
PMA NumberP880035
Supplement NumberS006
Date Received07/06/1993
Decision Date08/11/1993
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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