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. |
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Device | MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS |
Generic Name | Lens, contact (rigid gas permeable), extended wear |
Regulation Number | 886.5916 |
Applicant | MENICON CO. LTD. 21-19, Aoi 3-Chome, Naka-ku Nagoya Aichi 460-0-0006 |
PMA Number | P990018 |
Supplement Number | S004 |
Date Received | 04/01/2009 |
Decision Date | 02/25/2010 |
Product Code |
MWL |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - PAS |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR MODIFIED LABELING TO INCLUDE INFORMATION REGARDING THE POST-APPROVAL STUDY. |
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