MODEL AC-21 OMNIFIT ANTERIOR CHAMBER

FDA Premarket Approval P860034

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

DeviceMODEL AC-21 OMNIFIT ANTERIOR CHAMBER
Generic NameIntraocular Lens
ApplicantADVANCED MEDICAL OPTICS, INC.
Date Received1984-01-20
Decision Date1989-09-29
Notice Date1989-11-13
PMAP860034
SupplementS
Product CodeHQL 
Docket Number89M-0425
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
P860034Original Filing
S015 1997-06-30 Real-time Process
S014 1995-11-13 Normal 180 Day Track
S013 1995-11-03 Normal 180 Day Track
S012 1995-04-04 Normal 180 Day Track
S011 1994-01-13 Normal 180 Day Track
S010 1992-07-21 Normal 180 Day Track
S009 1992-06-30 Normal 180 Day Track
S008 1991-01-25 Normal 180 Day Track
S007 1990-02-28 Normal 180 Day Track
S006
S005
S004
S003
S002
S001

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