| Kendall Healthcare Products Company brochure entitled "A Clinically Proven Home Regimen to Treat Venous Insufficiency " (1989). |
| Kendall Healthcare Products Company Instruction Manual entitled "SCD.TM. Therapeutic System,"pp. 1-8 (1989). |
| Kendall Healthcare Products Company Sep. 1, 1993 letter and brochure entitled "T.E.D..RTM./SCD.TM. Compression System." |
| Kendall Healthcare Products Company brochure entitled "Making Prevention Operative,"(1991). |
| Kendall Healthcare Products Company information order form entitled "A Clinically Proven Home Regimen to Treat Venous Insufficiency,"(1989). |
| Kendall Healthcare Products Company brochure entitled "The Home Rx.TM. Vascular Compression System for Healing Venous Ulcers,"(1991). |
| Kendall T.E.D..RTM. Sequential Compression Device Model 5320 Operating Instructions, pp. 1-17, 1985. |
| Olson et al., "Experimental Studies of External Pneumatic Compression Methods on a Model Human Leg," 32nd ACEMB, Denver Hilton Hotel, Denver, CO, Oct. 6-10, 1979. |
| Salzman et al., "Effect of Optimization of Hemodynamics on Fibrolytic Activity and Antithrombotic Efficacy of External Pneumatic Calf Compression,"Annals of Surgery, vol. 206, No. 5, Nov. 1987, pp. 636-641. |
| Caprini, "Role of Compression Modalities in a Prophylactic Program for Deep Vein Thrombosis," Seminars in Thrombosis and Hemostasis--Supplement, vol. 14, 1988, pp. 77-87. |
| Hull, et al., "Effectiveness of Intermittent Pneumatic Leg Compression for Preventing Deep Vein Thrombosis After Total Hip Replacement," JAMA, vol. 263, No. 17, May 2, 1990, pp. 2313-2317. |
| Bucci, et al., "Mechanical Prophylaxis of Venous Thrombosis in Patients Undergoing Craniotomy: A Randomized Trial," Surg. Neurol. vol. 32, 1989, pp. 285-288. |
| Jobst brochure entitled, "Athrombic Pump.RTM.--System 2000--Intermittent Compression Device. ". |
| Jobst 510(k) Notice dated Sep. 25, 1989. Exhibits 1A-6G are attached as follows:. |
| Photographs of front and rear view of System 2000. |
| Photograph of System 2000 with wrap-around pneumatic sleeve and photograph of wrap-around pneumatic sleeve. |
| Photograph of System 2000 with disposable wrap-around pneumatic sleeve and photograph of disposable wrap-around pneumatic sleeve. |
| Instructions for operation of Athrombic Pump.TM. System 2000. |
| Instruction for operation of Jobst Athrombic Pump System Wrap-Around Pneumatic Sleeve. |
| Instructions for operation of Jobst Athrombic Pump System Disposable Wrap-Around Pneumatic Sleeve. |
| Instructions for operation of Athrombic Pump.TM. Model 116620, Form 586R6. |
| Instructions for operation of Jobst.TM. Anti-Em.TM. Extremitly Pump.TM., Model 116600, Form 582. |
| Front panel label (artwork)--condensed instructions for Jobst Athrombic Pump.TM. System 2000. |
| Date plate Label. |
| Front and back view of Wrap-Around Sleeve label. |
| Front and back view of Disposable Wrap-Around Sleeve label. |
| Description of Air Chamber label. |
| Jobst brochure entitled, "Venous Thrombosis in the High-Risk Patient", Form 945 (1987). |
| Jobst article entitled: "Deep Vein Thrombosis," Form 294R3 (1981). |
| Jobst brochure entitled, "Anti-Em.TM. Anti-Embolism Extremity Pump.RTM.," Form 639 (1974). |
| Kendall advertisement. |
| Kendall advertisement for T.E.D./SEC Compression System. |
| Kendall Model 5320 operating instructions--T.E.D..TM. Sequential Compression Device. |
| Baxter advertisement for Pulsatile Anti-Embolism System. |
| Gaymar Industries, Inc. advertisement for Thrombogard. |
| Lyne-Nicholson, Inc. advertisement for Venodyne. |
| Camp International, Inc. advertisement for Hemaflo. |
| Comparative Chart--Compression Systems for Treatment of D.V.T. |
| Salzman, et al., "Intraoperative external pneumatic calf compression to afford long-term prophylaxis against deep vein thrombosis in urological patients," Surgery, vol. 87, No. 3, 1980, pp. 239-242. |
| "Prevention of Venous Thrombosis and Pulmonary Embolism," National Institutes of Health Consensus Development Conference Statement Conference Statement, vol. 6, No. 2. |
| Hull et al., "Effectiveness of Intermittent Pulsatile Elastic Stockings for the Prevention of Calf and Thigh Vein Thrombosis in Patients Undergoing Elective Knee Surgery" (undated). |
| Coe et al., "Prevention of deep vein thrombosis in urological patients: A Controlled, randomized trial of low-dose heparin and external pneumatic compression boots," Surgery, vol. 83, No. 2, 1978, pp. 230-234. |
| Klein et al., "Prevention of Thromboembolism in Urological Patients" (undated). |
| Whalen et al., "Deep Vein Thrombosis--Prophylaxis" (undated). |
| Salzman et al., "Effect of Optimization of Hemodynamics on Fibrinolytic Activity and Antithrombotic Efficacy of External Pneumatic Calf Compression," Ann. Surg., vol. 206, No. 5, 1987, pp. 636-641. |
| Letter to Food and Drug Administration dated Dec. 20, 1989 supplementing 510(k). |
| Letter to Food and Drug Administration dated Nov. 9, 1989 supplementing 510(k). Exhibits 1-5D are attached as follows:. |
| Jobst Institute, Inc. Overview of Deep Vein Thrombosis, Pulmonary Embolism and Discussion of Prophylactic Methods. |
| Jobst Nov. 8, 1989 Memorandum to File from Kotwick Regarding: Evolution of the Design of the Jobst Athrombic Pump. |
| Jobst Institute, Inc., Engineering Study #89102, Introduction & Methods, Title: Electromagnetic Interference Considerations of the Jobst Athrombic Pump System 2000. |
| Jobst Institute, Inc., Engineering Study #89102, Results & Discussion. |
| Jobst Institute, Inc., Engineering Study #89101, Introduction & Methods, Title: Performance Comparison of the Jobst Athrombic Pumps. |
| Jobst institute, Inc., Engineering Study #89101, Results & Duscussion. |
| Graor et al., "The Comparative Evaluation of Deep Vein Thrombosis Prophylaxis in Total Joint Replacement Patents: An Interim Report," presented at the 1989 meeting of the American Academy of Orthopaedic Surgeons. |
| Salzman et al., "Prevention of Venous Thromboembolism in Unstable Angina Pectoris," The New England Journal of Medicine, vol. 306, No. 306, No. 16, 1982. |
| Moser, "Pulmonary thromboembolism: Your challenge is prevention," The Journal of Respiratory Diseases, vol. 10, No. 10, 1989, pp. 83-85, 88, 91-93. |
| Green et al., "Deep Vein Thrombosis in Spinal Cord Injury: Effect of Prophylaxis with Calf Compression, Aspirin, and Dipyridamole," paraplegia, vol. 20, 1982, pp. 227-234. |