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The intended use for the AART Pectoralis Implant is augmentation of the chest to add definition to the pectoralis muscle by placing submuscular. It may also be used for reconstruction of the pectoralis depression caused by Poland's Syndrome (congenitally absent pectoralis muscle).

The AART Pectoralis Implants are manufactured from a medical grade silicone elastomer that has been molded into various convex oval shapes. They are provided in three styles, each with a right and left mirror image. Dimensions of the implants will range from 14.4 cm to 17.6 cm in length with widths from 10.0 cm to 13.5 cm and projection (height) from 1.6 cm to 3.2 cm. The AART Pectoralis Implants are intended to be used for augmentation of the chest by placing the implant submuscular of the pectoralis muscle. They can also be used to reconstruct the pectoralis depression caused by Poland's Syndrome (congenitally absent pectoralis muscle). The surface characteristic of the implants is smooth. The AART Rectoralis. Implants will be offered non-sterile.

Seare Biomedical Pectoralis Implants / silicone carving blocks are intended to be used for augmenting the chest by placing the implant in the submuscular space via a trans-axillary incision. They can also be used to reconstruct the pectoralis depression of Poland's Syndrome (Congenitally Absent Pectoralis Muscle).

Searc Biomedical Pectoralis implants are essentially large conceve conver on interestion. They are exponied Device Description: Seare Bromsonally formulated silicone elastomers designed for implantation. They are novided in two (2) orientations for cach of the specially formation and only in the milablity. Surface characterity will way ironton beeks on intended to smooth to varying degrees of lexturing and pornsity. Seare Biometical Pectoralis Implants / silicone carving block same intended to smood for augmenting the chest by placing the inplant in the submuseular space via a trans-axillary incision. The Career Ricer be used to reconstruct the pectoralis depression of Poland's Syndrone Congenitally Absent Pectoralis Muscle). The Seare Biomedical used to reconstition the pectoralis deplession of rolance congramilar - differing in length and proccion. The length of these implants varies from 11.5cm to 20cm. The height varies from 9cm to 18cm and the thickness at the apex varies 1cm to 3.5cm. The Seare Biomedical Pectoralis Implants will be provided sterile and nonsterile.

Seare Biomedical Silicone Blocks are intended for use in the cosmetic correction of soft tissue deformities, and is contoured at the surgeon's discretion to create a custom implant to aid in the reconstruction process. The contour carving blocks lend themselves to carving chin implants and malar implants.

Searc Biomedical Silicone Blocks are made from specially formulated silicone elastomers designed for implantation, LSR soft implant grade silicone elastomer. The intended use of the Seare Biomedical silicone block is for caring a finished device by the surgeon for his or her own custom use. The square or rectangular blocks are designed for carving flater devices for use in bone onlay for correction of surface defects resulting from skeletal anomalies such as depressions secondary to trauma or cancer resection. The curved blocks are generally used for carved devices such as malar and chin implants. The Seare Biomedical Silicone Blocks will be provided sterile. The appearance is described as clear to slightly opaque. Pigments will optionally be added such as Iron Oxide, to create opacity to light and Radiographic exam.

The intended use of the Hanson Pectoralis Implant is augment or reconstruct the male chest by inserting the implant under the pectoralis muscle usually through a transaxillary incision. The proposed device can also be used for the correction of surface defects resulting from congenital anomalies such as depressions secondary to Poland's Syndrome. This product will be delivered non sterile. Silicone Carving Blocks are to be used for augmenting the chest by placing the implant in the submuscular space via a trans-axillary incision. They can also be used to reconstruct the pectoralis depression of Poland's Syndrome (Congenitally Absent Pectoralis Muscle)

The Hanson Pectoralis Implant is made from the same Silicone liquid elastomer materials and manufacturing processes as the predicate device. The physical properties of this device are the same as the predicate device in that the same materials or equivalent materials will be used. These raw materials are the LSR 30 of Applied Silicone and the MED 4211 unrestricted silicone fluid of Nusil Technologies. The durometers or hardness (Shore A) will range from 5 to 30. The appearance is described as clear to slightly opaque. The raw materials for these blocks will be Applied Silicone's LSR series and Nusil Unrestricted MED 4211. Tensile strength from lot to lot average 600 PSI or greater. The percent elongation is over 400 percent. Each lot is certified and tested for compliance to the parameters set for in the raw material certifications for each lot tested by the manufacturer. The Chemical components of this device are polysiloxanes catalyzed by a two part system.