WET-N-SOAK(TM) REWETTING DROPS

FDA Premarket Approval P900047 S004

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 steri-tech, inc. , p. O. Box 1145, salinas, puerto rico 00751 as an alternate contract sterilization site, and for the use of 100% ethylene oxide to sterilize plastic bottles, tips, and caps used in the manufacture of the device

DeviceWET-N-SOAK(TM) REWETTING DROPS
Generic NameAccessories, Soft Lens Products
ApplicantADVANCED MEDICAL OPTICS, INC.
Date Received1995-06-08
Decision Date1996-02-23
PMAP900047
SupplementS004
Product CodeLPN 
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonLocation 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
P900047Original Filing
S005 1996-03-01 Normal 180 Day Track
S004 1995-06-08 Normal 180 Day Track
S003 1995-05-05 Normal 180 Day Track
S002 1994-01-21 Normal 180 Day Track
S001

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