Food and Drug Administration

General and Plastic Surgery Devices Panel Meeting

July 8, 2002

Briefing Information

The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.

Information for Classification of Silicone elastomer for Scar Management

June 11, 2002 Scar Management Device memo from Dr. Sam Arepalli, PhD  doc  pdf

Proposed Identification for the Scar Management Device  doc  pdf

Scar Management Device Literature  doc  pdf

Scar Management Device Medical Device Report Summary  doc  pdf

Scar Management Device Panel Issues  doc  pdf

Information for Reclassification of Absorbable Hemostatic Agent and Dressing Devices

Proposal to Reclassify the Absorbable Hemostatic Agent Device memo from  Dr. David Krause, PhD  doc  pdf

Absorbable Hemostatic Device Identification Proposal  doc  pdf

Reclassification Issues  doc  pdf

Comments Regarding Classification of Silicone Sheeting for Scar Management, Johnson & Johnson Consumer Products Co.  pdf