Antiplatelets are medications that inhibit the activity of platelets, which help the blood clot after injury.Antiplatelets are used to avoid situations where the blood can clot excessively, potentially causing a heart attack or stroke.Under normal circumstances, platelets play a crucial role in blood coagulation, clotting and hemostasis (stoppage of bleeding).ntiplatelets are medications that inhibit the activity of platelets, which help the blood clot after injury.
DRAFT MEDICAL DEVICE GUIDANCE MAY 2014 ___________________________________________________________________________________________ HEALTH SCIENCES AUTHORITY â HEALTH PRODUCTS REGULATION GROUP Page 9 of 13 appropriate, the method of re-sterilisation and any restriction on the number of reuses.
Contrasted with the premarket notification process, the PMA (premarket approval) process is more rigorous because it requires a device sponsor to demonstrate that its device is safe and effective for its intended use, based on scientific evidence.lass III medical devices, or high-risk medical devices, are typically subject to the most stringent regulatory requirements, including the submission of a premarket approval application (âPMAâ).