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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 (TM)
Generic NameLens, contact (other material) - daily
ApplicantMenicon Co, Ltd.
269 A Ballardvale St.
Wilmington, MA 01887
PMA NumberP880098
Supplement NumberS011
Date Received06/13/2000
Decision Date09/06/2000
Withdrawal Date05/05/2008
Product Codes HQD MWL 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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