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The Tactra™ device is designed to provide penile rigidity and the device can be placed in either an erect or a concealed position. The Tactra Penile Prosthesis is a sterile, single-use implant that is intended for use in the treatment of chronic, organic, erectile dysfunction (impotence) in adult males who are determined to be suitable candidates for implantation surgery.

The Tactra Penile Prosthesis is a sterile, single-use implant that is intended for use in the treatment of chronic, organic, erectile dysfunction (impotence) in adult males who are determined to be suitable candidates for implantation surgery. The Tactra Penile Prosthesis is a malleable implant which consists of a pair of cylinders which are surgically implanted, one into each corpus cavernosum, to provide penile rigidity for adult males with erectile dysfunction. The two cylinders are available in diameters of 9.5 mm, 11 mm, and 13 mm. The proximal end of each cylinder has an 8 cm trimmable zone for length adjustment as desired by the physician. The working length of each cylinder is the total length including the "0" cm Rear Tip Extenders (RTE). Since each cylinder has an 8 cm zone to be trimmed, the working length for each diameter cylinder encompasses the range shown in the table below. If additional length is needed, alternate RTEs (0.5 cm or 1 cm) can be attached to the proximal end of each cylinder prior to implantation. All components consist of implantable, biocompatible materials and are provided as sterile, single-use implants. These implants may not be re- sterilized.

The malleable penile prosthesis is indicated for implantation into the corpora cavernosa of the penis in men who are diagnosed with erectile dysfunction. The prosthesis is implanted to provide adequate penile rigidity for sexual intercourse. The prosthesis is designed for the treatment of organic erectile dysfunction in men due to: Pelvic fracture, Spinal cord injury or disease, Prostatectomy,Multiple sclerosis, Diabetes mellitus, Arteriosclerosis, Hypertensive vascular disease, Priapism, Peyronie's disease, Selectively for psychogenic impotence.

Rigi10 malleable penile prosthesis is a sterile, non-pyrogenic, single-use surgical implant. The device core consists of a malleable stainless-steel core, with titanium caps on both ends, and a PTFE (Polytetrafluoroethylene) tube cover. The entire outside surface of the cylinder is made out of silicone. The malleable stainlesssteel core enables the prosthesis to be moved into an erect position when desired and also enables the concealment of the prosthesis under clothing. All components consist of implantable, biocompatible materials. The device consists of two cylinders, and extenders. The cylinders are surgically implanted, one into each corpus cavernosum, to provide penile rigidity. The prosthesis comes in two lengths. This includes 23 cm and 25 cm. The length is determined by the diameter of the prosthesis. Rigi10 Malleable Penile Prosthesis is available in five different diameter sizes; 9 mm, 10 mm, 11 mm, 12 mm, and 13 mm. Cylinders with 9 mm and 10 mm diameters are available in 23 cm length while cylinders with 11mm, 12 mm and 13 mm diameters are available in 25 cm length. There are four extenders (two pieces of 0.5 cm and two pieces of 1.0 cm) included in each product package. The extenders are accessories of the device and are available for adjusting the length of the prosthesis to match the total corporal measurement of the patient.

The AMS Spectra™ Concealable Penile Prosthesis is a sterile, non-pyrogenic, single-use implant that is intended for use in the treatment of chronic, organic, erectile dysfunction (impotence) in men who are determined to be suitable candidates for implantation surgery.

The AMS Spectra™ Concealable Penile Prosthesis consists of a pair of cylinders which are surgically implanted, one into each corpus cavernosum, to provide penile rigidity. Each device consists of two cylinders and may include rear tip extenders (RTEs) for additional length. All components consist of implantable, biocompatible materials. The cylinder consists of a malleable section of articulating polymer and metal segments. A cable extends through the center of the articulating segments. The proximal and distal ends of the cable are each connected to a spring that is encased in a metal housing. The entire outside surface of the cylinder is made of silicone. The articulating segments, held together by the cable and spring assemblies, provide sufficient friction and rigidity. This allows the patient to position the device for concealment or for intercourse. Spectra cylinders are available in 9.5-, 12-, and 14-mm diameters. Each cylinder diameter is available in three lengths: 12-, 16-, and 20-cm. The total cylinder length can be adjusted by adding rear tip extenders (RTEs) to the proximal cylinder end. A range of RTE lengths is included to accommodate the patient's total intracorporal length. Rear tip extenders may be attached to the Spectra™ cylinders in 0.5-cm increments, and may extend the cylinder lengths from 0.5- to 7.5-cm, with the exception of 7-cm. The RTEs are the same as those used with the inflatable AMS 700™ CXR and CX/LGX models (D970012). These RTE components' functional performance has been demonstrated in use with the 700™ IPP products.

The AMS Spectra™ Concealable Penile Prosthesis is a sterile, nonpyrogenic, single-use implant that is intended for use in the treatment of chronic, organic, erectile dysfunction (impotence) in men who are determined to be suitable candidates for implantation surgery.

The AMS Spectra™ Concealable Penile Prosthesis consists of a pair of cylinders which are surgically implanted, one into each corpus cavernosum, to provide penile rigidity. Each device consists of two cylinders and may include rear tip extenders (RTEs) for additional length. All components consist of implantable, biocompatible materials. The cylinder consists of a malleable section of articulating polymer segments. A cable extends through the center of the articulating segments. The proximal and distal ends of the cable are each connected to a spring that is encased in a metal housing. The entire outside surface of the cylinder is made of silicone. The articulating segments, held together by the cable and spring assemblies, provide sufficient friction and rigidity. This allows the patient to position the device for concealment or for intercourse. Spectra cylinders are available in 9.5-, 12-, and 14-mm diameters. Each cylinder diameter is available in three lengths: 12-, 16-, and 20-cm. The total cylinder length can be adjusted by adding rear tip extenders (RTEs) to the proximal cylinder end. A range of RTE lengths is included to accommodate the patient's total intracorporal length. Rear tip extenders may be attached to the Spectra™ cylinders in 0.5-cm increments, and may extend the cylinder lengths from 0.5- to 7.5-cm, with the exception of 7-cm. The RTEs are the same as those used with the inflatable AMS 700™ CXR and CX/LGX models (D970012.) These RTE components' functional performance has been demonstrated in use with the 700™ IPP products.

The Mentor Genesis Penile Prosthesis is designed for the management of impotence stemming from a variety of causes, including epispadias; pelvic fracture; spinal cord injury or disease; prostatectomy; abdominal-perineal resection; multiple sclerosis; diabetes mellitus; alcoholism; arteriosclerosis and hypertensive vascular disease; priapism; and Peyronie's disease. The Prosthesis may also be used in selected patients with psychogenic impotence.

The Genesis Penile Prosthesis is a flexible silicone elastomer device designed to be implanted into the penis for the management of erectile dysfunction (commonly known as impotence). The Prosthesis (used in pairs) is inserted into the corpora cavernosa. Each Prosthesis consists of a r roothed in panel in panel is a silver wire coil and silver wire coil and silver wire core in the flexible center section and a trimmable proximal section. The distal end is shaped to provide an anatomical fit under the glans penis. The silver wire coil and core in the flexible center section anatelinear in antost the gost into an erect position for intercourse, and then moved into a lowered position for concealment under clothing. Placed within the corpus cavernosum and crus of the penis, the Prosthesis will fit firmly at the ischial tuberosity. The ends fit the proximal culde-sacs of the cavernosa and provide support to the Prosthesis. All components of the Genesis Penile Prosthesis incorporate a hydrophilic coating on all external surfaces.

The AMS Ambicor Penile Prosthesis is intended for use in the treatment of chronic, organic, male erectile dysfunction (impotence) in men who, after appropriate patient history, diagnostic evaluation and discussions with the urologist of other alternative treatment methods, are determined to be suitable candidates for implantation surgery.

The Ambicor Penile Prosthesis is a device intended for implantation in the body to correct erectile impotence. The device consists of two cylinders and a single pump. The cylinders are implanted in the corpora cavernosa of the penis and a pump which is implanted in the scrotum. Each time the pump bulb is squeezed, saline is pumped from the reservoir into the cylinders. This step produces the inflation that makes the penis rigid. The Ambicor Penile Prosthesis is deflated by bending the penis (and specifically, the cylinders) to a 55 - 65° angle and maintaining that position for 6-12 seconds before releasing. The device comes with 12 rear tip extenders (RTE). Each RTE provides 0.5 cm of additional length to the device. A total of 12 RTEs are packaged with each device, potentially providing an additional 3.0 cm of length expansion per cylinder (6 RTEs/cylinder). The device consists primarily of silicone elastomers, incorporates polyester fabric, an expanded polytetrafluoroethylene (PTFE) sleeve, a polyacetal, and stainless steel components.