COMPLETE BRAND LUBRICATING AND REWETTING DROPS

FDA Premarket Approval P910075 S008

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 a change in the sterilizing filter (0. 22 micron)

DeviceCOMPLETE BRAND LUBRICATING AND REWETTING DROPS
Generic NameAccessories, Soft Lens Products
ApplicantADVANCED MEDICAL OPTICS, INC.
Date Received1996-07-11
Decision Date1996-09-05
PMAP910075
SupplementS008
Product CodeLPN 
Advisory CommitteeOphthalmic
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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