MEDICAL DEVICES DISPUTE RESOLUTION PANEL
September 6, 2001
PMA (P990015) As Amended for INTERGEL Adhesion Prevention Solution
BRIEFING INFORMATION
FOOD AND DRUG ADMINISTRATION
Ombudsman’s Summary of the Scientific Issues in Dispute pdf htm
FDA Summary of Arguments pdf htm
FDA Lead Reviewer Summary pdf htm
FDA Statistical Review pdf htm
FDA Summary Clinical Reviews with Attachments
FDA Summary Clinical Reviews pdf htm
Attachment 1: P990015a11 Ob Gyn Consult Review pdf htm
Attachment 2: Tables: G950025s26, P990015a7; P990015a11 pdf
FDA Slides
Introduction to FDA Presentations ppt htm
INTERGEL Adhesion Prevention Solution Clinical Study of Use during Laparotomy for Gynecologic Interventions Lifecore Biomedical, Inc., FDA Clnical Perspective, Roxolana Horbowyj, MD ppt htm
Statistical Review of Intergel, Richard Kotz ppt htm
LIFECORE BIOMEDICAL, INC.
Disclaimer
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.
Sponsor's Request for Dispute Resolution Panel Review (Including Summary of Arguments) pdf
Investigational Protocol pdf
Amendment 10 (11) to PMA (Including Draft Summary of Safety and Effectiveness and Draft Labeling)
June 2, 2000 Letter from The Weinberg Group Inc pdf
Section I. Cover Letter pdf
Section II. Indications of Use pdf
Section III. Amendment to Clinical Trial Report: Protocol PTL-0013/0022, May 31, 2000 pdf
Section IV. Safety of Intergel® Solution for Use in Gynecological Pelvic Surgery pdf
Appendix A. Clinical Validation of the American Fertility Society Adnexal Adhesion Scoring System: Review of the Literature pdf
Attachment A. pdf
Attachment B. pdf
Attachment C. pdf
Attachment D. pdf
Appendix B. Effect of Intergel® Solution on Mortality and Abscess Formation After Intraperiotoneal Infection in Rats. Study Report, May 30, 2000 pdf
Appoendix C. Summary of Safety and Effectiveness (Revised) pdf
Appendix D. Clinical Trial Report. Protocol PTL-0013/0022. Clinical Evaluation of Lubricoat 0.5% Ferric Hyaluronate Gel for the Reduction of Adhesions Following Peritoneal cavity Surgery, A Multicenter Study of Safety and Efficacy. March 4, 1999
Part 1 pdf
Part 2 pdf
Sponsor's Corrections to Administrative Record pdf
Summary of Opinions By Clinical Experts Retained by Sponsor pdf
Summary of Opinions By Statistical Experts Retained by Sponsor pdf