X-70 SOFT CONTACT LENS

Lenses, Soft Contact, Extended Wear

FDA Premarket Approval P830047

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

DeviceX-70 SOFT CONTACT LENS
Classification NameLenses, Soft Contact, Extended Wear
Generic NameLenses, Soft Contact, Extended Wear
ApplicantADVANCED MEDICAL OPTICS, INC.
Date Received1983-07-28
Decision Date1985-03-29
Notice Date1985-05-10
PMAP830047
SupplementS
Product CodeLPM
Docket Number85M-0166
Advisory CommitteeOphthalmic
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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