|
Device | ULTRA CARE (TM) NEUTRALIZING TABLET |
Generic Name | Accessories, soft lens products |
Regulation Number | 886.5928 |
Applicant | ADVANCED MEDICAL OPTICS, INC. 2525 DUPONT DR. IRVINE, CA 92612 |
PMA Number | P850088 |
Supplement Number | S036 |
Date Received | 08/23/1996 |
Decision Date | 07/03/1997 |
Product Code |
LPN |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR AN ALTERNATE FORMULATION USING CATALASE RAW MATERIAL DERIVED FROM A NON-ANIMAL SOURCE AND AN ASSOCIATED CHANGE IN THE MINIMUM NEUTRALIZATION SOAK TIME FROM 2 TO 4 HOURS. THE ALTERNATE FORMULATION INCLUDES NO CHANGES IN THE INDICATIONS FOR USE. |