This article was originally published in The Gray Sheet
Executive SummaryAgency's Center for Devices and Radiological Health issues "Guidance Document for Vascular Prostheses 510(k) Submissions," developed "as a special control to support reclassification from Class III to Class II for vascular graft prostheses," Nov. 26. The center simultaneously issues "Guidance for Annuloplasty Rings 510(k) Submissions," also as a special control, and "Guidance for Cardiovascular Intravascular Filter 510(k) Submissions," which supersedes the agency's Feb. 11, 1997 guidance on premarket notification for the same devices. Draft "Guidance for Resorbable Adhesion Barrier Devices for Use in Abdominal and/or Pelvic Surgery" is also available for comment on CDRH web site
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