RESOLVE/GP(TM) DAILY CLEANER

FDA Premarket Approval P870026 S006

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 isotron ireland, ltd. Located at sragh industrial estate, tullamore, co. Offaly, ireland, as an alternate contract sterilization iste, and for the use of 100% ethylene oxide to sterilize the plastic bottles, tips, and caps

DeviceRESOLVE/GP(TM) DAILY CLEANER
Generic NameAccessories, Soft Lens Products
ApplicantADVANCED MEDICAL OPTICS, INC.
Date Received1995-05-05
Decision Date1996-04-12
PMAP870026
SupplementS006
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
P870026Original Filing
S007 1995-06-08 Normal 180 Day Track
S006 1995-05-05 Normal 180 Day Track
S005 1992-06-04 Normal 180 Day Track
S004 1990-07-25 Normal 180 Day Track
S003 1990-01-09 Normal 180 Day Track
S002 1989-09-29 Normal 180 Day Track
S001 1988-04-14 Normal 180 Day Track

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