2005P-0085
Volume 1
CP 1

Citizen Petition

Index

Tab 1 - United States Surgical Corporation, 510(k) No. K971680, Oct. 24, 1997

Tab 2 - CP Medical, Inc., 510(k) No. K024372, June 19, 2003

Tab 3 - Jordi Letter, dated July 14, 2003

Tab 4 - Miscellaneous Promotional Material for Kits Using Bone Wax or “Faux Bone Wax” Plugs

Tab 5 - American Cancer Society Website

Tab 6 - Louis Potters, MD., Permanent Prostate Brachytherapy in Patients with Clinically Localized Prostate Cancer, Men’s Health and Cancer

Tab 7 - Subir Nag, M.D., et al.,Pulmonary Embolization of Permanently Implanted Radioactive Palladium 103 Seeds for Carcinoma in the Prostate, 39 Int. Journal of Radiation Oncology Biol. Phys. 667 (1997)

Tab 8 - Literature for Brachytherapy Kits Without Bone Wax or “Faux Bone Wax” Plugs

Tab 9 - Ole-Gunnar, M.D. et al, Complications Secondary to the Use of Standard Bone Wax in Seven Patients, 32 The Journal of Ankle and Foot Surgery 505 (1993)

Tab 10 - James Aurelio, D.D.S., et al, Foreign-body Reaction to Bone Wax, 58(1) Oral Surgery, Oral Medicine, oral Pathology 98 (1984)

Tab 11 - Blake A. Morrison, M.D., Soft Tissue Sarcomas of the Extremities, 16 BUMC Proceedings 285 (2003)

Tab 12 - Bayram Cirak, M.D. and Oscan Ulna, M.D., Estrogenic quadriplegia and bone wax, 92 J. Neurosurgery: Spine 248 (April 2000)

Tab 13 - W.K. Low and C.S. Sim, Bone Wax Foreign Body Granuloma in the Mastoid, 64 ORL. 38 (2002)

Tab 14 - Farah Bhatti, BestBets: Best Evidence Topics, Literature Review: Does Liberal Use of Bone Wax Increase the Risk of Mediastinitis?

Tab 15 - Rakesh B. Patel, M.D., et al, Bone Wax as a Cause of Foreign Body Granuloma in the Berebellopontine Angle, J. Neurosurg. 362 (2000)

Tab 16 - Francis Robicsek, M.D., The Embolization of Bone Wax from Stemotomy Incisions, 31 Annals of Thoracic Sugery 357 (1980)

Tab 17 - Belen Carsi, M.D., Ph.D., Angiosarcoma, 2 eMedicine Journal (Dec. 2001)

Tab 18 - Medical Device Reporting (“MDR”) Database, No. M751327, dated April 4, 1996

Tab 19 - MDR Database, No. M476758, dated Feb. 7, 1994

Tab 20 - MDR Database, No. M213158, dated Oct. 23, 1990

Tab 21 - MDR Database, No. M178314, dated Dec. 1, 1989

Tab 22 - MDR Database, No. M178143, dated Nov. 29, 1989

Tab 23 - MDR Database, No. M154511, dated May 20, 1988

Tab 24 - MDR Database, No. M125866, dated July 15,1986

Tab 25 - MDR Database, No. M117354, dated Jan. 13, 1986

Tab 26 - MDR Database, No. M101751, dated Feb. 15, 1985

Tab 27 - Robert A. Older, et al, Radioactive Implant Migration in Patients Treated for Localized Prostate Cancer with Interstitial Brachytherapy, 165 The Journal of Urology 1590 (2001)

Tab 28 - Murali K. Ankem, Implications of Radioactive Seed Migration to the Lungs After Prostate Brachytherapy, 59(4) Urology 555 (2002)

Tab 29 - Brian J. Davis, Prostate Brachytherapy Seed Migration to the Right Ventricle Found at Autopsy Following Acute Cardiac Dysrhythmia, 164 The Journal of Urology 1661 (2000)

Tab 30 - Brian J. Davis, et al, Prostate Brachytherapy Seed Migration to a Coronary Artery Found During Angiography, 168 The Journal of Urology 1103 (2002)

Tab 31 - Ethicon Bone Wax Package Insert

Tab 32 - World Wide Medical Technologies, 510(k) No. K022389, May 6, 2003

Tab 33 - Imagyn Medical Technologies, 510(k) No. K010166, Dec. 3, 2001

Tab 34 - John E. Sylvester, M.D., Modern Brachytherapy, Oncology Issues (May/June 2002)

Tab 35 - Labeling Information for Monocryl

Tab 36 - Ethicon, Inc., 510(k) No. K964072, Dec. 18, 1996

Tab 37 - MonocryI (Poliglecaprone 25) Information Sheet

Tab 38 - Indigo Medical Co., 510(k) No. K992262, Oct. 4, 1999

Tab 39 - World Wide Medical Technologies, 510(k) No. K991344, Nov. 5, 1999

Tab 40 - IBt EZ-Pak Brachytherapy Kit, 510(k) No. K041702, JuIy 16, 2004

Tab 41 - IBt Interstrand, 510(k) No. K011155, July 12, 2001

Tab 42 - IBt Intersource, 510(k) No. K984235, June 9, 1999

Tab 43 - IBt Intersource (Interseed), 510(k) No. K973328, Dec. 10, 1998

Tab 44 - IBt Interstrand Advertising

Tab 45 - BEBIG Brachytherapy Kit, 510(k) No. K040339, Apr. 8, 2004