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Jobst Ready-To-Use Arm Sleeve may be used under the direction of a healthcare professional to manage the flowing conditions: Edema Mild to moderate lymphedema Phlebitis Post-thrombotic syndrome Vascular Malformations Hypertrophic scars

This submission covers JOBST Ready-To-Wear Compression Arm Sleeves, which fall under the device classification of medical support stockings (21 CFR §880.5780). They are equivalent to the preamendment Jobst-Custom garments, and the SIGVARIS 902/503 Arm Sleeves, which are used for the same indications. While Jobst-Custom garments are cut and sewn from fabric made of spandex and nylon varns, the SIGVARIS 902 and JOBST Ready-To-Wear Arm Sleeves are circular knit with spandex and nylon yarns. The sizing of the Ready-To-Wear Arm Sleeves is based on circumferential measurements of the wrist, forearm and mid-upper arm and is limited to people whose arm dimensions fall within the specified ranges. The Jobst-Custom garments are sized based on measurements taken every inch and a half. They can be made to fit a wider range of limb dimensions and a wider range of compression as needed by the individual patient. Compression is provided for all of these products by large elastic yarns that act circumferentially on the limb. The gradient compression present in these products helps to force fluid into the deep venous system and helps in the return of lymphatic fluid.

Cutinova thin is a dressing indicated for the management of surface wounds with low to moderate exudate, such as: Minor burns Abrasions Cutinova thin may also be used under the direction of a health care professional for partial thickness wounds such as: Second degree burns Leg ulcers Pressure ulcers Post-op wounds Donor sites

Cutinova thin is a polyurethane dressing that is indicated for the management of wounds with low to moderate exudate. The current modification involves a change in the material used to make the urethane from an aromatic diisocyanate to an aliphatic diisocyanate and does not affect the indications for use.

Cutinova hydro is indicated for the management of surface, moderately to highly secreting wounds such as: Leg ulcers Stage I-IV pressure ulcers First and second degree burns

Cutinova hydro is a polyurethane dressing that is indicated for the management of moderately to highly exudating wounds. The current modification involves a change in the material used to make the urethane from an aromatic diisocyanate to an aliphatic disocyanate and does not affect the indications for use.

Cutinova cavity is indicated for the management of deep secondary healing wounds such as: Cavity wounds Stage III and IV pressure ulcers Deep leg ulcers Excisions Post-op wound dehiscence

Cutinova cavity is a polyurethane dressing that is indicated for the management of deep secondary healing wounds. The current modification involves a change in the material used to make the urethane from an aromatic disocyanate to an aliphatic diisocyanate and does not affect the indications for use.

Cutinova foam is indicated for the management of surface, moderately to highly secreting wounds surrounded by sensitive skin, such as: Stage I-IV pressure ulcers Leg ulcers Diabetic ulcers First and second degree burns Cutinova foam may be used under the direction of a health care professional for the management of moderately to highly exudating wounds surrounded by sensitive skin, such as: Pressure ulcers Leg ulcers Diabetic ulcers Second degree burns

Cutinova foam is a polyurethane dressing that is indicated for the management of moderately to highly exudating wounds surrounded by sensitive skin. The current modification involves a change in the material used to make the urethane from an aromatic diisocyanate to an aliphatic diisocyanate and does not affect the indications for use.