OMNIFLEX(TM) SOFBLUE(R) HYDROPHILIC CONTACT LENSES

Lenses, Soft Contact, Extended Wear

FDA Premarket Approval P830047 S006

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

DeviceOMNIFLEX(TM) SOFBLUE(R) HYDROPHILIC CONTACT LENSES
Classification NameLenses, Soft Contact, Extended Wear
Generic NameLenses, Soft Contact, Extended Wear
ApplicantADVANCED MEDICAL OPTICS, INC.
Date Received1991-04-18
Decision Date1991-07-26
PMAP830047
SupplementS006
Product CodeLPM
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address ADVANCED MEDICAL OPTICS, INC. 1700 E. St. Andrew Place p.o. Box 25162 santa Ana, CA 92705-4933

Supplemental Filings

Supplement NumberDateSupplement Type
P830047Original Filing
S006 1991-04-18 Normal 180 Day Track
S005
S004 1989-07-20 Normal 180 Day Track
S003 1987-08-04 Normal 180 Day Track
S002 1987-07-21 Normal 180 Day Track
S001 1986-09-12 Normal 180 Day Track
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