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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 SF-P RGP (MELAFOCON A) CONTACT LENS
Classification Namelenses, soft contact, daily wear
Generic Namelenses, soft contact, daily wear
Regulation Number886.5925
Applicant
MENICON CO. LTD.
269a ballardvale st.
wilmington, MA 01887
PMA NumberP880098
Supplement NumberS001
Date Received07/24/1989
Decision Date02/08/1990
Product Code
LPL[ Registered Establishments with LPL ]
Docket Number 90M-0068
Notice Date 03/08/1990
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
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