Ao_statement : APPROVAL FOR THE PROTOCOL TO BE USED TO ADD CONTACT LENS FINISHING LABORATORIES TO MANUFACTURE THE SUBJECT DEVICE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME BOSTON ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENS FOR OVERNIGHT WEAR FOR BAUSCH & LOMB VISION SHAPING TREATMENT AND IS INDICATED FOR USE IN THE REDUCTION OF MYOPIC REFRACTIVE ERROR IN NON-DISEASED EYES. THE LENSES ARE INDICATED FOR OVERNIGHT WEAR FOR THE TEMPORARY REDUCTION OF MYOPIA UP TO 5.00 DIOPTERS WITH EYES HAVING ASTIGMATISM UP TO 1.5 DIOPTERS. THE LENSES MAY ONLY BE DISINFECTED USING A CHEMICAL DISINFECTION SYSTEM. NOTE: TO MAINTAIN THE ORTHOKERATOLOGY EFFECT OF MYOPIA REDUCTION, OVERNIGHT LENS WEAR MUST BE CONTINUED ON A PRESCRIBED SCHEDULE. FAILURE TO DO SO CAN AFFECT DAILY ACTIVITIES (E.G., NIGHT DRIVING), VISUAL FLUCTUATIONS AND CHANGES IN INTENDED CORRECTION.
Ao_statement : Approval for the device which will be marketed under the trade name PD-L1 IHC 28 - 8 pharmDx and is indicated for a qualitative immunohistochemical assay using Monoclonal Rabbit Anti-PD-L1, Clone 28-8 intended for use in the detection of PD-L1 protein in formalin-fixed, paraffin-embedded (FFPE) non-squamous non-small cell lung cancer (NSCLC) and melanoma tissues using EnVision FLEX visualization system on Autostainer Link 48. PD-L1 protein expression is defined as the percentage of evaluable tumor cells exhibiting partial or complete membrane staining at any intensity. PD-L1 expression as detected by PD-L1 IHC 28-8 pharmDx in non-squamous NSCLC may be associated with enhanced survival from OPDIVO® (nivolumab). Positive PD-L1 status as determined by PD-L1 IHC 28-8 pharmDx in melanoma is correlated with the magnitude of the treatment effect on progression-free survival from OPDIVO®.