ULTRAZYME PROTEIN CLEANER

FDA Premarket Approval P860061 S005

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

DeviceULTRAZYME PROTEIN CLEANER
Generic NameAccessories, Soft Lens Products
ApplicantADVANCED MEDICAL OPTICS, INC.
Date Received1989-08-21
Decision Date1991-03-25
PMAP860061
SupplementS005
Product CodeLPN 
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address ADVANCED MEDICAL OPTICS, INC. 2525 Dupont Dr. irvine, CA 92612

Supplemental Filings

Supplement NumberDateSupplement Type
P860061Original Filing
S010 1995-06-06 Normal 180 Day Track
S009 1994-03-24 Normal 180 Day Track
S008 1993-11-16 Normal 180 Day Track
S007 1992-09-11 Normal 180 Day Track
S006 1991-10-30 Normal 180 Day Track
S005 1989-08-21 Normal 180 Day Track
S004 1989-01-25 Normal 180 Day Track
S003 1988-03-01 Normal 180 Day Track
S002 1987-06-23 Normal 180 Day Track
S001 1987-06-08 Normal 180 Day Track

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