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The MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs can be utilized for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision and tissue defect procedures. The expander is intended for temporary subcutaneous or submuscular implantation and is not intended for use beyond six months.

The PliaForm™ Breast Tissue Expander w/ Suture Tabs is designed for breast reconstruction, designed for thinner components and a reduction of reinforcement features and minimized insertion profile. The integrated port design consists of a plastic needle guard and a smaller magnetic element to improve MR compatibility (MR Conditional). The next generation design control technology (DCT) facilitates predictable expansion and is shape-optimized to better match the entire implant portfolio. An improved Bufferzone features a new sheeting-based self-sealing technology that offers protection from inadvertent needle punctures across the entire coverage area, and a more flexible design, which improves the overall device flexibility. An internally fixated injection port reduces device bulkiness. The injection port will incorporate a new plastic needle guard with a silicone backing and smaller magnet with reduced magnetic field strength compared to the Artoura™ breast tissue expander devices. This feature reduction improves device compatibility with MR-CT imaging, and external beam radiation (such as photon beam). Identification of the injection port site is accomplished by use of the CENTERSCOPE™ 2.0 Magnetic Injection Port Locator, which is provided with the Tissue Expander. When the Centerscope™ 2.0 device is placed on top of the skin, the magnetic arm points to the center of the tissue expander's injection port. Injections into the injection port area are made using the provided infusion needle set to inject sterile, pyrogen-free Sodium Chloride U.S.P. Solution. The MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs incorporates suture tabs to provide surgeons with the option to attach the device to surrounding tissue for enhanced device stability. The MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs are provided sterile in three styles (Low Height, Medium Height, and Tall Height) and various sizes. The following accessories are packaged with the MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs: - Centerscope™ 2.0 Magnetic Injection Port Finder - Winged Infusion Set (21G)

The MENTOR™ CPX™4 PLUS Enhance Smooth Breast Tissue Expander with fill volume to 1445cc can be used for breast reconstruction after mastection of an underdeveloped breast, scar revision and tissue defect procedures. The devices are intended for temporary subcutaneous or submuscular implantation and are not intended for use beyond six months.

The MENTOR™ CPX™4 PLUS Enhance Breast Tissue Expander is used for breast reconstruction following mastectomy and is intended for temporary subcutaneous or submuscular implantation and is not intended for use beyond six months. The proposed device consists of a smooth surface shell made with successive cross-linked layers of silicone elastomer identical to the predicate device (K241918). Again, identical to the predicate device, the subject device contains superior and anterior reinforcement which allows for directional expansion in the lower pole of the device has an integral, silicone elastomer, magnetically detected, injection dome and incorporates a BUFFERZONE™ area with self-sealing technology (containing silicone gel) to the front patch of the device to minimize and/or prevent leakage in the event of an accidental needle puncture. The CPX™4 PLUS Enhance Breast Tissue Expander Injection Dome houses a rare-earth, permanent magnet. This internal magnet, when in conjunction with the CENTERSCOPE™ Magnetic Injection Port Locator accessory, helps the injector accurately identify the injection dome during patient tissue expander fill procedures.

The MENTOR™ MemoryGel™ Enhance Single Use Gel Breast Implant Sizer is indicated for single use only for temporary insertion intraoperatively to evaluate the shape and size of the MemoryGel™ Enhance Breast Implanted.

The MENTOR™ MemoryGel™ Enhance Single Use Gel Breast Implant Sizer (Sizer) is a silicone elastomer device, filled with silicone gel, that is designed for temporary intraoperative placement in the surgically prepared breast pocket. The Sizer is used to evaluate the appropriate MemoryGel™ Breast Implant size and shape for each patient prior to implantation of a breast implant. It is provided sterile and is for single use only. The Sizer should not be resterilized.

The Mentor™ CPX™4 PLUS Enhance Smooth Breast Tissue Expander with fill volume to 1445cc can be used for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision and tissue defect procedures. The devices are intended for temporary subcutaneous or submuscular implantation and are not intended for use beyond six months.

The MENTOR™ CPX™4 PLUS Enhance Breast Tissue Expander is used for breast reconstruction following mastectomy and is intended for temporary subcutaneous or submuscular implantation and is not intended for use beyond six months. The proposed device consists of a smooth surface shell made with successive cross-linked layers of silicone elastomer. Superior and anterior reinforcement allows for directional expansion in the lower pole of the device has an integral, silicone elastomer, magnetically detected, injection dome and incorporates a BUFFERZONE™ area with selfsealing technology (containing silicone gel) to the front patch of the device to minimize and/or prevent leakage in the event of an accidental needle puncture. The CPX™4 PLUS Enhance Breast Tissue Expander Injection Dome houses a rare-earth, permanent magnet, This internal magnet, when in conjunction with the CENTERSCOPE™ Magnetic Injection Port Locator accessory, helps the injector accurately identify the injection dome during patient tissue expander fill procedures. Identification of the injection dome site can be accomplished by use of the CENTERSCOPE™ Magnetic Injection Port Locator provided with the Tissue Expander. Instructions for use of the CENTERSCOPE™ Magnetic Injection Port Locator are provided within this document. Injections must be made using sterile, pyrogen-free Sodium Chloride U.S.P. Solution and into the injection dome area. If injections are made on or outside the injection dome, leakage can occur. The MENTOR™ CPX™4 PLUS Enhance Smooth Breast Tissue Expander gives surgeons the option to attach the device to surrounding tissue to enhance device stability. Surgeons can suture on any part of the tab surface or the suturing hole can be used for added convenience. The MENTOR™ CPX™4 PLUS Enhance Smooth Breast Tissue Expander, Catalogue Number SCPX-15TH-E, provides fill volume options from 930 cc to 1445 cc. The following accessories are packaged with the CPX™4 PLUS Enhance Breast Tissue Expander: - Centerscope Magnetic Injection Port Finder . - Winged Infusion Set .

The CPX 14 Breast Tissue Expanders with Smooth Surface can be utilized for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision and tissue defect procedures. The expander is intended for temporary subcutaneous or submuscular implantation and is not intended for use beyond six months.

The CPX™4 Tissue Expanders with Smooth Surface consist of a silicone elastomer shell, with superior and anterior reinforcement that allows for directional expansion in the lower pole of the device. The device has an integral, silicone elastomer, magnetically detectable injection port. The injection port also incorporates a BUFFERZONE® area with self-sealing technology which is attached to the inside of the anterior surface of the device. The BUFFERZONE® is intended to minimize and/or prevent leakage in the event of an accidental needle puncture. Identification of the injection port site is accomplished by use of the CENTERSCOPE® Magnetic Injection Port Locator, which is provided with the Tissue Expander. When the Centerscope device is placed on top of the skin, the magnetic arm points to the center of the tissue expander's injection dome. Injections into the injection dome area are made using the provided infusion needle set to inject sterile, pyrogen-free Sodium Chloride U.S.P. Solution. The CPX™4 Tissue Expanders with Smooth Surface incorporate suture tabs to provide surgeons with the option to attach the device to surrounding tissue for enhanced device stability. The CPX™4 Tissue Expanders with Smooth Surface are provided sterile. The devices are provided in three styles (Low, Medium and Tall) and in various sizes. The following accessories are packaged with the CPX™4 Tissue Expanders with Smooth Surface: Centerscope Magnetic Injection Port Finder, Winged Infusion Set.

The Mentor® ArtouralM Breast Tissue Expanders with Smooth Surface can be utilized for breast reconstruction after mastectony, correction of an underdeveloped breast, scar revision and tissue defect procedures. The expander is intended for temporary subcutaneous or submuscular implantation and is not intended for use beyond six months.

MENTOR® ARTOURA™ Breast Tissue Expanders with Smooth Surface consist of a silicone elastomer shell, with interior structural elements to allow for directional expansion in the lower pole of the device. The device has an integral, silicone elastomer, magnetically detectable injection port. The injection port also incorporates a BUFFERZONE® area with self-sealing technology which is attached to the inside of the anterior surface of the device. The BUFFERZONE® is intended to minimize and/or prevent leakage in the event of an accidental needle puncture. Identification of the injection port site is accomplished by use of the CENTERSCOPE® Magnetic Injection Port Locator, which is provided with the Tissue Expander. When the Centerscope device is placed on top of the skin, the magnetic arm points to the tissue expander's injection dome. Injections into the injection dome area are made using the provided infusion needle set to inject sterile, pyrogen-free Sodium Chloride U.S.P. Solution. The MENTOR® ARTOURA™ Breast Tissue Expanders with Smooth Surface incorporate suture tabs to provide surgeons with the option to attach the device to surrounding tissue for enhanced device stability. The MENTOR® ARTOURA™ Breast Tissue Expanders with Smooth Surface are provided sterile in two styles (High and Ultra High) and various sizes. The following accessories are packaged with the MENTOR® ARTOURA™ Breast Tissue Expanders with Smooth Surface: . Centerscope Magnetic Injection Port Finder . Winged Infusion Set

The CPX4 (TM) Breast Tissue Expanders can be utilized for breast reconstruction after mastection of an underdeveloped breast, scar revision and tissue defect procedures. The expander is intended for temporary subcutaneous or submuscular implantation and is not intended for use beyond six months.

The Mentor® CPX™4 Breast Tissue Expander consists of a silicone elastomer shell, with superior and anterior reinforcement to allow for directional expansion in the lower pole of the device. The device has an integral, silicone elastomer, magnetically detectable injection port. The injection port also incorporates a BUFFERZONE@area with self-sealing technology which is attached to the inside of the anterior surface of the device. The BUFFERZONE®is intended to minimize and/or prevent leakage in the event of an accidental needle puncture. Identification of the injection port site is accomplished by use of the CENTERSCOPE®Magnetic Injection Port Locator, which is provided with the Tissue Expander. When the CENTERSCOPE® device is placed on top of the skin, the magnetic arm points to the tissue expander's injection dome. Injections into the injection dome area are made using the provided infusion needle set to inject sterile, pyrogen-free Sodium Chloride U.S.P. Solution. The Mentor® CPX™4 Breast Tissue Expander incorporates suture tabs to provide surgeons with the option to attach the device to surrounding tissue for enhanced device stability. The Mentor® CPX™4 Breast Tissue Expander are provided sterile and deflated. The proposed Mentor® CPX™4 Breast Tissue Expander is provided in Tall Height Style with fill volume range from 850 cc to 1445 cc.

The MENTOR® MemoryShape™ Resterilizable Gel Breast Implant Sizer is indicated for temporary insertion intra-operatively to evaluate the size and shape of the MemoryShape™ breast implant to be implanted.

The MENTOR® MemoryShape™ Resterilizable Gel Breast Implant Sizer STERILE (Gel Sizer) is designed for temporary intra-operative placement in the surgically prepared breast pocket. The Gel Sizer is used to evaluate the appropriate breast implant size and shape for each patient prior to implantation of a MemoryShape™ (contour shape) breast implant. The Gel Sizer is provided sterile and can be used out of the box for the initial use. The Gel Sizer is then resterilized 9 additional times for a total of 10 uses. The MemoryShape™ sizers are offered in various sizes to match the corresponding MemoryShape™ breast implants. These gel sizers contain raised orientation marks on the anterior and posterior of the device to help the physician with placement.

The Artoura (TM) Breast Tissue Expanders can be utilized for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision and tissue defect procedures. The expander is intended for temporary subcutaneous or submuscular implantation and is not intended for use beyond six months.

The Mentor® Artoura™ Breat Tissue Expander consists of a silicone elastomer shell, with interior structural elements to allow for directional expansion in the lower pole of the device. The device has an integral, silicone elastomer, magnetically detectable injection port. The injection port also incorporates a BUFFERZONE® area with self-sealing technology which is attached to the inside of the anterior surface of the device. The BUFFERZONE®is intended to minimize and/or prevent leakage in the event of an accidental needle puncture. Identification of the injection port site is accomplished by use of the CENTERSCOPE® Magnetic Injection Port Locator, which is provided with the Tissue Expander. When the Centerscope device is placed on top of the skin, the magnetic arm points to the center of the tissue expander's injection dome. Injections into the injection dome area are made using the provided infusion needle set to inject sterile, pyrogen-free Sodium Chloride U.S.P. Solution. The Mentor® Artoura™ Breast Tissue Expander incorporates suture tabs to provide surgeons with the option to attach the device to surrounding tissue for enhanced device stability. The Mentor® Artoura™ devices are provided sterile in various styles and sizes. The following accessories are packaged with the Artoura™ Tissue Expander: . Centerscope Magnetic Injection Port Finder . Winged Infusion Set

The CPX(TM) Control Breast Tissue Expanders can be utilized for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision and tissue defect procedures. The expander is intended for temporary subcutaneous or submuscular implantation and is not intended for use beyond six months.

The CPX™ Control Breast Tissue Expander consists of a silicone elastomer shell, with interior structural elements to allow for directional expansion in the lower pole of the device. The device has an integral, silicone elastomer, magnetically detectable injection port. The injection port also incorporates a BUFFERZONE® area with self-sealing technology which is attached to the inside of the anterior surface of the device. The BUFFERZONE® is intended to minimize and/or prevent leakage in the event of an accidental needle puncture. Identification of the injection port site is accomplished by use of the CENTERSCOPE® Magnetic Injection Port Locator, which is provided with the Tissue Expander. When the Centerscope device is placed on top of the skin, the magnetic arm points to the center of the tissue expander's injection dome. Injections into the injection dome area are made using the provided infusion needle set to inject sterile, pyrogen-free Sodium Chloride U.S.P. Solution. The MENTOR CPX™ Control Breast Tissue Expander incorporates suture tabs to provide surgeons with the option to attach the device to surrounding tissue for enhanced device stability. The CPX Control devices are provided sterile in various styles and sizes. The following accessories are packaged with the CPX Control Tissue Expander: Centerscope Magnetic Injection Port Finder, Winged Infusion Set.