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

Not-Approvable Letter   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