|
Linda D'Abate has more than 20 years of experience in the medical device industry, with significant contributions and accomplishments in the field of cardiovascular intervention. She has previously worked as Vice President of Regulatory and Clinical Affairs for such companies as The Weinberg Group, Rubicon Medical, TherOx, Inc., Micro Therapeutics, Inc., and Pilot Cardiovascular Systems, Inc. Ms. D'Abate has provided independent consulting on clinical and regulatory affairs for many clients working with new technology devices with particular emphasis on significant risk (Class II and Class III) devices. She has excellent working knowledge of FDA and international pre-market acceptance applications and processes and has taken products from the concept stage through design validation, clinical trials, and eventual product approval. Ms. D'Abate has extensive experience in protocol development for critical device studies, as well as responsibility for preparation and implementation and approval of Investigational Device Exemptions Applications, 510(k)s and PMAs. She has also interfaced and worked with the FDA on conflict resolution, pre-IDE Meetings, protocol development, and postmarket studies. She has experience in due diligence reviews and assessments for industry acquisition and critical review of scientific literature and support to counsel in litigation. She has also presented at major regulatory meetings on the FDA regulatory and clinical process. She has both State Board Certification and National Board Certification in Radiologic Technology. |
MANAGEMENT TEAM
|
Linda D’Abate
Notice: The Coherex FlatStent EF PFO Closure System has been CE Marked and is currently distributed outside the U.S.A. and Japan by Abbott Vascular. It is not available for investigational use or for commercial distribution at this time in the U.S.A.
