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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.
 
DeviceMENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS
Generic NameLens, contact (rigid gas permeable), extended wear
Regulation Number886.5916
ApplicantMENICON CO. LTD.
21-19, Aoi 3-Chome, Naka-ku
Nagoya Aichi 460-0-0006
PMA NumberP990018
Supplement NumberS001
Date Received07/28/2000
Decision Date09/06/2000
Product Code MWL 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL OF PROCEDURES TO ADD LENS FINISHING LABORATORIES AS MANUFACTURERS AND DISTRIBUTORS OF CLASS III RGP EXTENDED WEAR CONTACT LENSES.
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