Tenaxis Medical, Inc. Announces ‘Fileable’ Status of PMA
MOUNTAIN VIEW, Calif., Oct. 25 /PRNewswire/ — Tenaxis Medical submitted its PMA to the FDA on July 27, 2010 and has now received confirmation from the FDA that “we have made a threshold determination that the PMA is sufficiently complete to permit a substantive review and is, therefore, suitable for filing.”
In the pivotal study designed to demonstrate superiority, the ArterX Surgical Sealant was compared to a thrombin soaked gelatin-sponge hemostat to reduce or eliminate suture line bleeding. President & Chief Executive Officer, David Smith commented, “We are delighted that the FDA has made the determination to substantively review the PMA. We are continuing to prepare for our US launch and this was an important milestone.”
About Tenaxis Medical, Inc.
Incorporated in 2004 and located in Mountain View, CA, Tenaxis Medical, Inc. is a privately held company. It develops novel, high performance sealants for use in vascular and general surgery. In addition to the ArterX Surgical Sealant, the company is developing a second high performance sealant for use throughout the gastrointestinal tract, and an anti-adhesion agent that can be delivered laparoscopically to help prevent or reduce pelvic and abdominal adhesions.
CONTACT: Ronald Dieck, +1-650-691-9016, ext. 110, for Tenaxis Medical, Inc.
SOURCE Tenaxis Medical, Inc.