MODEL AC-21 OMNIFIT ANTERIOR CHAMBER

FDA Premarket Approval P860034 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

DeviceMODEL AC-21 OMNIFIT ANTERIOR CHAMBER
Generic NameIntraocular Lens
ApplicantADVANCED MEDICAL OPTICS, INC.
Date Received1990-02-28
Decision Date1990-06-15
PMAP860034
SupplementS007
Product CodeHQL 
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonLocation Change - Manufacturer/sterilizer/packager/supplier
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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.