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The Medtronic Model 10626 Myocardial Implant Tool is used to facilitate myocardial pacing lead placement. It is designed to assist in the placement and manipulation of the Model 5071 myocardial pacing lead.

The implant tool consists of a handle, malleable shaft and lead hub fixation assembly (tongs) which grab and release a Model 5071 lead when the springloaded button actuator is depressed and released. The handle assembly includes a rotable, thumbwheel. Rotation of this thumbwheel in a clockwise direction results in equivalent rotation of a lead hub fixation assembly located at the distal end of the tool. Depression of the actuator allows fixation to the Model 5071 lead and also activates the fixation release upon completion of implant. Release of the actuator activates the fixation of the tool to the Model 5071 lead.

The indications or intended use for the DLP Octopus™ Tissue Stabilizer and the predicate product, Cardiothoracic Systems, Inc. (CTS) Thoracic Access Platform and Stabilizer are the same. Both are intended for use du ring coronary artery bypass grafting to isolate diseased artery and minimize motion of the beating heart to facilitate the grafting procedure.

The design of the Octopus"" is similar to both predicate products referenced in the Comparison Information Section. It features plastic handle with vacuum tubing connection, malleable stainless steel arm and suction tip similar to the DLP Cardiac Suction Tube product. The "feet" design of the Octopus" is intended to position the anastomosis site between two "feet" for isolation and stabilization control which is the same as the CTS Thoracic Access Platform and Stabilizer.

SPECIFIC INDICATION OF USE: PATENT DUCTUS ARTERIOSUS INTERRUPTION INTENDED USES: intended for use for General Pediatric Surgery where visualization in confined anatomic spaces minimizing tissue trauma are needed. These instruments are designed to be used in Video-Assisted Thoracoscopic Surgery (VATS). Where size constraints are limiting and immature tissues are potentially vulnerable to mechanical injury. INDICATIONS: Pediatric Thoracoscopic Procedures Patent Ductus Arteriosus Interruption (PDA) CONTRA INDICATIONS: For PDA patients with a ductal diameter over 1 cm calcification, presence of a transcatheter device within the ductal lumen, patients with dense pleural adhesions.

These instruments are equivalent to Thoracoscopy instruments for adult sizes but have a reduced dimension with a modified geometric configuration to meet reduced size requirements. These are modifications therefore of equivalent surgical instruments that can be used in general pediatric surgery but also have been designed specifically for pediatric thoracoscopic surgery. Instruments that are needed for the surgical procedures are cannula, lung retractor, clip appliers, grasping forceps with ratchets, scissors, hooks, and clamps. These instruments have specific overtures and dimensions suited for this surgical procedure.