DURASOFT4 (OFILCON A) CONTACT LENSES/SHELF LIFE

Lenses, Soft Contact, Extended Wear

FDA Premarket Approval P850072 S007

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

DeviceDURASOFT4 (OFILCON A) CONTACT LENSES/SHELF LIFE
Classification NameLenses, Soft Contact, Extended Wear
Generic NameLenses, Soft Contact, Extended Wear
ApplicantCIBA VISION CORPORATION
Date Received1989-09-25
Decision Date1990-03-09
PMAP850072
SupplementS007
Product CodeLPM
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address CIBA VISION CORPORATION 11460 Johns Creek Parkway duluth, GA 30097

Supplemental Filings

Supplement NumberDateSupplement Type
P850072Original Filing
S007 1989-09-25 Normal 180 Day Track
S006 1989-09-18 Normal 180 Day Track
S005 1989-09-11 Normal 180 Day Track
S004 1989-07-20 Normal 180 Day Track
S003 1989-02-09 Normal 180 Day Track
S002 1987-11-12 Panel Track
S001 1986-08-05 Normal 180 Day Track

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