|
Device | ALLERGAN(R) PRESERVED SALINE SOL.SPEC CHANGE |
Generic Name | Accessories, soft lens products |
Regulation Number | 886.5928 |
Applicant | ADVANCED MEDICAL OPTICS, INC. 2525 DUPONT DR. IRVINE, CA 92612 |
PMA Number | N18020 |
Supplement Number | S040 |
Date Received | 05/30/1995 |
Decision Date | 09/20/1995 |
Product Code |
LPN |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A REVISED PACKAGE INSERT TEXT WHICH IS TO BE PRINTED ON THE 8 FL. OZ AND 15 FL. OZ. AEROSOL CANS OF THE REFERENCED DEVICE AND THE ELIMINATION OF THE PACKAGE INSERT FOR THESE SIZE CONTAINERS |