Pediatric cardiovascular device registries--the need for such data and the potential impact.
Joseph
Francesca
F
US Food & Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD 20993, USA. francesca.joseph@fda.hhs.gov
D000367:Age Factors; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation*; D002309:Cardiology / Q000295:instrumentation*; D002318:Cardiovascular Diseases / Q000628:therapy*; D018795:Device Approval; D004867:Equipment Design; D019317:Evidence-Based Medicine; D006801:Humans; D010372:Pediatrics / Q000295:instrumentation*; D011474:Prosthesis Design; D012042:Registries; D018570:Risk Assessment; D016896:Treatment Outcome