MainCumulative percent of approved 180-day PMA supplement review memos posted during the month (1)Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury. PMA is the most stringent type of device marketing application required by FDA. The applicant must receive FDA approval of its PMA application prior to marketing the device. PMA approval is based on a determination by FDA that the PMA contains sufficient valid scientific evidence to assure that the device is safe and effective for its intended use(s).A 180-day PMA supplement is a supplemental application to an approved PMA for approval of significant changes that affect the safety and effectiveness of the device. This measure quantifies ODE’s ability to inform the public of the status of 180-day PMA supplements for which the sponsor is seeking approval to a change or modification of an approved PMA. Expedient posting of review memos will provide transparency to the public regarding modifications to PMA devices.(1) Measure was implemented starting January 1, 2010.Percentline01002010TargetCumulative FY 2010 Target: 80%FY 2010 Overall: 90%SubCumulative percent of approved 180-day PMA supplement review memos posted during the month (1)Number of approved 180-day PMA supplement review memos posted during the monthNumbercolumn2010TargetFY 2010 Total: 19SubCumulative percent of approved 180-day PMA supplement review memos posted during the month (1)Number of approved 180-day PMA supplements during the monthNumbercolumn2010TargetFY 2010 Total: 21http://www.fda.gov/AboutFDA/Transparency/track/ucm203038FDA-TRACK CDRH Dashboardtrack?program=cdrh&id=CDRH-ODE-Percent-180-day-PMA-supplement-approval-memos-on-web-in-60-daysPercent of 180-day PMA supplement summary review memos posted on the web within 60 days from approval to posting during the month਍††਍਍਍਍਍਍਍