TEAR REWETTER

FDA Premarket Approval P800065 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

DeviceTEAR REWETTER
Generic NameAccessories, Soft Lens Products
ApplicantADVANCED MEDICAL OPTICS, INC.
Date Received1982-02-25
Decision Date1982-07-02
PMAP800065
SupplementS001
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
P800065Original Filing
S015 1995-06-08 Normal 180 Day Track
S014 1995-05-05 Normal 180 Day Track
S013 1989-09-29 Normal 180 Day Track
S012 1988-05-27 Normal 180 Day Track
S011 1988-04-14 Normal 180 Day Track
S010 1988-02-24 Normal 180 Day Track
S009 1986-08-15 Normal 180 Day Track
S008 1986-10-16 Normal 180 Day Track
S007 1984-06-04
S006 1984-04-23
S005 1983-10-12
S004 1983-01-25
S003 1982-12-20
S002 1982-04-20
S001 1982-02-25

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