MENICON SF-P (MELAFOCON A) CONTACT LENS

Lenses, Soft Contact, Extended Wear

FDA Premarket Approval P880098 S009

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.

Pre-market Approval Supplement Details

Approval for labeling changes including adding to the approved labeling allergan inc. 's destat 4 system and alcon laboratories, inc. 's opti-soak system. No furhter changes will be made in the labeling.

DeviceMENICON SF-P (MELAFOCON A) CONTACT LENS
Classification NameLenses, Soft Contact, Extended Wear
Generic NameLenses, Soft Contact, Extended Wear
ApplicantMENICON CO. LTD.
Date Received1996-01-04
Decision Date1996-04-03
PMAP880098
SupplementS009
Product CodeLPM
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address MENICON CO. LTD. 269a Ballardvale St. wilmington, MA 01887

Supplemental Filings

Supplement NumberDateSupplement Type
P880098Original Filing
S012 2002-11-19 Real-time Process
S011 2000-06-13 Normal 180 Day Track
S010 1997-06-30 Normal 180 Day Track
S009 1996-01-04 Normal 180 Day Track
S008 1995-05-15 Special (immediate Track)
S007
S006 1993-03-01 Normal 180 Day Track
S005 1991-08-08 Normal 180 Day Track
S004 1990-02-13 Normal 180 Day Track
S003 1989-12-01 Normal 180 Day Track
S002 1989-10-06 Normal 180 Day Track
S001 1989-07-24 Normal 180 Day Track

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