HealthTronics OssaTron Lithotripter PMA Submission Planned By Year-End
This article was originally published in The Gray Sheet
Executive Summary
A premarket approval application for HealthTronics' OssaTron lithotripter for treatment of chronic heel pain due to planar fasciitis should be submitted to FDA by December.
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HealthTronics' OssaTron Lithotriptor Approvable For Heel Spur Pain - Panel
HealthTronics' OssaTron orthopedic lithotriptor should be approved for treatment of plantar fasciitis (heel spurs), rather than the more general indication of chronic heel pain syndrome, FDA's Orthopedic and Rehabilitation Devices Panel suggested.
HealthTronics' OssaTron Lithotriptor Approvable For Heel Spur Pain - Panel
HealthTronics' OssaTron orthopedic lithotriptor should be approved for treatment of plantar fasciitis (heel spurs), rather than the more general indication of chronic heel pain syndrome, FDA's Orthopedic and Rehabilitation Devices Panel suggested.
HealthTronics OssaTron
Lithotripter premarket approval application submission to FDA covers treatment of plantar fasciitis (heel spurs). The filing had been delayed pending feedback from the agency on clinical trial results (1"The Gray Sheet," Sept. 6, p. 18). The 30-month, multi-site, double-blind study included over 300 patients. The Marietta, Georgia company also is pursuing additional orthopedic applications, including lateral epicondylitis (tennis elbow) and non-union fractures, for which ongoing studies will be expanded in early 2000