SOFT-FORM 55EW; LL-55; SOFTCON EW2

Lenses, Soft Contact, Extended Wear

FDA Premarket Approval P890040 S008

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

Increase to the sterilization load size to utilize more of the chamber capacity.

DeviceSOFT-FORM 55EW; LL-55; SOFTCON EW2
Classification NameLenses, Soft Contact, Extended Wear
Generic NameLenses, Soft Contact, Extended Wear
ApplicantUnilens Corp., USA
Date Received2016-02-04
Decision Date2016-02-29
PMAP890040
SupplementS008
Product CodeLPM
Advisory CommitteeOphthalmic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Unilens Corp., USA 10431 72nd St. North largo, FL 33777

Supplemental Filings

Supplement NumberDateSupplement Type
P890040Original Filing
S008 2016-02-04 30-day Notice
S007 2013-07-08 30-day Notice
S006 2007-12-31 135 Review Track For 30-day Notice
S005 1998-11-04 Normal 180 Day Track
S004 1991-11-25 Normal 180 Day Track
S003 1991-02-11 Normal 180 Day Track
S002 1990-10-02 Normal 180 Day Track
S001 1989-10-10 Normal 180 Day Track

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