Neurorecovery(R), Inc. Receives FDA Pre-Market Clearance Letter for Improved CIPER(R) Kit
Posted on: Friday, 22 July 2005, 12:01 CDT
TUSCLOOSA, Ala., July 22 /PRNewswire/ -- Neurorecovery, Inc., today announced that it has received a FDA pre-market clearance letter for the 510(k) it submitted for its improved version of its CIPER Kit.
"This is an important event in the development of Neurorecovery's medical device product line. With this clearance letter, Neurorecovery has now completed the FDA clearance process for all of its core neurological intracranial pressure (ICP) evaluation and management products," Landon Miller, Neurorecovery's President and CEO, said.
The newly cleared CIPER kit's indicated use is:
"The Neurorecovery(R), Inc. Comprehensive Intracranial Pressure Evaluation and Relief Kit (NRI CIPER(R) Kit) is intended for single patient use for the measurement of intracranial pressures (ICP) and drainage of Cerebral Spinal Fluid (CSF). It is intended for short term management of patients with increased intracranial pressure."
Neurorecovery, Inc. is a patient-focused pharmaceutical and medical delivery system company whose corporate mission is to enhance drug delivery and enabling methods for patients suffering from neurological injuries and diseases, while addressing important societal issues related to those injuries and diseases. The company intends to achieve its goals by developing and bringing to market products with a proven efficacy and which meet significant -- and unmet -- medical needs throughout the injury cycle, and by utilizing an innovative business model that integrates academic research, business best practices, and the social needs of the world's population. Neurorecovery, Inc. is based in Tuscaloosa, Ala.
Web site: http://www.neurorecoveryinc.com/
Neurorecovery, Inc.
CONTACT: John Casey of Neurorecovery, Inc., +1-205-345-0149
Web site: http://www.neurorecoveryinc.com/
Source: PRNewswire
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