WESLEY-JESSEN (R) WJD-1 MULTI-PURPOSE SOLUTION

FDA Premarket Approval P910075 S001

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

DeviceWESLEY-JESSEN (R) WJD-1 MULTI-PURPOSE SOLUTION
Generic NameAccessories, Soft Lens Products
ApplicantADVANCED MEDICAL OPTICS, INC.
Date Received1994-06-30
Decision Date1995-04-28
PMAP910075
SupplementS001
Product CodeLPN 
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
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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