Arlyss
Well-known member
There is a center within the FDA that deals with medical devices, including prosthetic heart valves.
On their website, there are public health notices such as the following about valves and other products from Shelhigh, Inc.
http://www.fda.gov/cdrh/safety/041907-shelhigh.html
http://www.fda.gov/cdrh/medicaldevicesafety/atp/041907-shelhigh.html
There is also a searchable database of reports submitted to them about devices, including heart valves. As mentioned on the search web page, the data is not intended to determine the rate of problems or to compare problems across different devices. However, it is another public source of information. Here is the link to the search page
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.cfm
Best wishes,
Arlyss
On their website, there are public health notices such as the following about valves and other products from Shelhigh, Inc.
http://www.fda.gov/cdrh/safety/041907-shelhigh.html
http://www.fda.gov/cdrh/medicaldevicesafety/atp/041907-shelhigh.html
There is also a searchable database of reports submitted to them about devices, including heart valves. As mentioned on the search web page, the data is not intended to determine the rate of problems or to compare problems across different devices. However, it is another public source of information. Here is the link to the search page
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.cfm
Best wishes,
Arlyss
