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LTM-Laparoscopic Surgical Mesh is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. Indications for use include the repair of hernias and/or body wall defects which require the use of reinforcing or bridging material to obtain the desired surgical outcome during open or laparoscopic procedures. LTM-Laparoscopic Surgical Mesh is intended for single patient one-time use only.

L TM-Laparoscopic Surgical Mesh is a surgical mesh that is derived from porcine dermis and is processed and preserved in a phosphate buffered aqueous solution containing matrix stabilizers. This device is designed to perform as a surgical mesh for soft tissue repair while presenting a scaffold to the patient. The device consists of a terminally sterilized sheet of the processed porcine dermal matrix provided in prescribed geometric configurations and thicknesses and is packaged in a double pouch configuration. The proposed device has the same scientific technology, principles of operation, Intended Use, and Indications for Use as the cleared predicate device, LTM-Laparoscopic Surgical Mesh (K121289). The only change described in this submission is a minor modification to the Instructions for Use. There have been no changes made to the physical LTM-Laparoscopic Surgical Mesh device. The Instructions for Use have been modified to describe fixation of the device by sutures and surgical tacks, according to surgeon preference. The Instructions for Use previously provided as part of the cleared predicate device (K121289) described suturing LTM-Laparoscopic Surgical Mesh into position.

LTM-Laparoscopic Surgical Mesh is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. Indications for use include the repair of hernias and/or body wall defects which require the use of reinforcing or bridging material to obtain the desired surgical outcome during open or laparoscopic procedures. LTM-Laparoscopic Surgical Mesh is intended for single patient one-time use only.

The LTM-Laparoscopic Surgical Mesh is a surgical mesh that is derived from porcine dermal tissue. The LTM-Laparoscopic Surgical Mesh device consists of a terminally sterilized sheet of the processed porcine dermal matrix provided in prescribed geometric configurations and sizes ranging from 10 cm x 16 cm to 20 cm x 20 cm, with future sizes planned ranging from 2 cm x 2 cm to 20 cm x 30 cm. It will be packaged in double pouch configuration.