ENZYME/ SURFACTANT TABLET

Accessories, Soft Lens Products

FDA Premarket Approval P880053 S003

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

DeviceENZYME/ SURFACTANT TABLET
Classification NameAccessories, Soft Lens Products
Generic NameAccessories, Soft Lens Products
ApplicantADVANCED MEDICAL OPTICS, INC.
Date Received1989-05-11
Decision Date1989-11-17
PMAP880053
SupplementS003
Product CodeLPN
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address ADVANCED MEDICAL OPTICS, INC. 2525 Dupont Dr. irvine, CA 92612

Supplemental Filings

Supplement NumberDateSupplement Type
P880053Original Filing
S007 1991-01-30 Normal 180 Day Track
S006 1990-09-26 Normal 180 Day Track
S005 1990-08-08 Normal 180 Day Track
S004 1989-07-14 Normal 180 Day Track
S003 1989-05-11 Normal 180 Day Track
S002
S001 1989-04-17 Normal 180 Day Track

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