COMPLETE BRAND LUBRICATING AND REWETTING DROPS

FDA Premarket Approval P910075 S009

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

Approval for use of a new method to assay the active ingredient, polyhexamethylene biguanide (phmb)

DeviceCOMPLETE BRAND LUBRICATING AND REWETTING DROPS
Generic NameAccessories, Soft Lens Products
ApplicantADVANCED MEDICAL OPTICS, INC.
Date Received1996-09-06
Decision Date1996-09-24
PMAP910075
SupplementS009
Product CodeLPN 
Advisory CommitteeOphthalmic
Supplement TypeSpecial (immediate Track)
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address ADVANCED MEDICAL OPTICS, INC. 2525 Dupont Dr. irvine, CA 92612

Supplemental Filings

Supplement NumberDateSupplement Type
P910075Original Filing
S009 1996-09-06 Special (immediate Track)
S008 1996-07-11
S007 1996-05-02 Normal 180 Day Track
S006 1995-06-08 Normal 180 Day Track
S005 1995-05-05 Normal 180 Day Track
S004 1995-04-06 Normal 180 Day Track
S003 1995-02-02 Normal 180 Day Track
S002 1993-08-02 Normal 180 Day Track
S001 1994-06-30 Normal 180 Day Track

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