Food and Drug Administration

General and Plastic Surgery Devices Panel

November 21, 2003

Briefing Information

Morning Session

Executive Secretary Cover Letter (HTM) (PDF) (Word)

FDA Cancer Risk Assessment (HTM) (PDF) (Word)

FDA Clinical Summary (HTM) (PDF) (Word)

FDA Cover Letter (HTM) (PDF) (Word)

FDA Summary Lead Review Memorandum (HTM) (PDF) (Word)

FDA Pathologist Review (HTM) (PDF) (Word)

FDA Statistical Review (HTM) (PDF) (Word)

FDA Preclinical Summary (HTM) (PDF) (Word)

Afternoon Session

FDA P030032 Hylaform Clinical (HTM) (PDF) (Word)

FDA Preclinical Review (HTM) (PDF) (Word)

FDA Hylaform Final Statistical Review (HTM) (PDF) (Word)

Clinical Study (Redacted), Genzyme Corp. (PDF)

Non-Clinical Section, Genzyme Corp. (PDF)