Brookfield, Wisconsin (PRWEB) December 03, 2012
InControl Medical, LLC., a leading provider of medical devices treating female incontinence and sexual dysfunction, including the InToneTM non-implanted electrical stimulator, announced today that it received a warning letter from the Food and Drug Administration (FDA) on November 15, 2012 relating to various documentation and administrative deficiencies. The warning letter does not allege any issues relating to the safety or effectiveness of the InTone device and the Company continues to stand 100% behind the safety and effectiveness of the product. There have been no reports of any safety issues, defects or deficiencies in the InTone device. In fact, the InTone device is currently resulting in an approximate 97% cure rate of female urinary incontinence within 30-60 days of beginning treatment.
The warning letter addresses issues primarily related to the establishment of standard operating procedures, the documentation of procedures, and the maintenance of records. Herschel Peddicord, Chief Executive Officer of the Company said, “InControl Medical recognizes the importance of the identified documentation and administrative issues and values and respects FDA’s input and observations. The Company has been actively working on these issues for several months and has hired a new Quality Management System Administrator who is addressing all issues identified by FDA and with the full support and resources of the Company.”
Since receiving the warning letter, InControl Medical’s FDA regulatory counsel at Foley & Lardner LLP has contacted FDA and acknowledged the receipt of the warning letter. The Company is actively preparing its response and intends to fully respond within the time frame outlined in the letter.
Said Mr. Peddicord, “The Company’s goal is to be fully compliant with all FDA regulations and looks forward to working closely with the Agency in fully addressing all of its concerns. Our number one priority has always been and remains patient safety and providing patients with safe and effective devices for the treatment of urinary incontinence.”
About InControl Medical, LLC
InControl Medical, LLC. is a leading provider of medical devices treating female urinary incontinence. For more information, visit http://www.InControlMedical.com.
InControl Medical, LLC
Chief Executive Officer