|
Device | UNPRESERVED CONSEPT-2 RINSING & NEUTRALIZING SOL. |
Generic Name | Accessories, soft lens products |
Regulation Number | 886.5928 |
Applicant | ADVANCED MEDICAL OPTICS, INC. 2525 DUPONT DR. IRVINE, CA 92612 |
PMA Number | P840066 |
Supplement Number | S029 |
Date Received | 10/03/1991 |
Decision Date | 02/29/1996 |
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 THE UNPRESERVED FORMULATION OF CONSEPT-2 NEUTRALIZING AND RINSING SOLUTION TO BE PACKAGED IN A NON-AEROSOL MULTI-DOSE 8 AND 12 FLUID PZ CONTAINERS WITH A FILTER/VALVE CLOSURE SYSTEM LABELED WITH A DISCARD DATE OF 60 DAYS |