WET-N-SOAK

FDA Premarket Approval P870037 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 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, itps, and caps used in the manufacture of the devices

DeviceWET-N-SOAK
Generic NameAccessories, Soft Lens Products
ApplicantADVANCED MEDICAL OPTICS, INC.
Date Received1995-06-08
Decision Date1996-02-23
PMAP870037
SupplementS008
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
P870037Original Filing
S008 1995-06-08 Normal 180 Day Track
S007 1995-05-05 Normal 180 Day Track
S006 1989-09-29 Normal 180 Day Track
S005 1989-09-07 Normal 180 Day Track
S004 1988-12-12 Normal 180 Day Track
S003 1988-04-14 Normal 180 Day Track
S002 1987-10-30 Normal 180 Day Track
S001 1987-10-30 Normal 180 Day Track

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