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CSDP April 6, 2021 Agenda
… regarding the premarket approval application (PMA) for the TransMedics® Organ Care System™ (OCS) – Heart System [OCS™ … 9:15 a.m. Welcome & Introduction (FDA) 9:30 a.m. Transmedics® Presentations (90 min) Questions to Transmedics® (15 min) 11:15 a.m. Break (15 min) 11:30 a.m. …
SRO Added - June 2019
… Silk Road Medical, Inc. USA SILK NASDAQ 117042075 Transmedics Group, Inc. USA TMDX NASDAQ 078751728 …
CSDP April 6, 2021 24 Hour Summary
… Summary of the Circulatory System Devices Panel Meeting TransMedics Organ Care System (OCS) Heart System April 6, … and make recommendations on the PMA application for the TransMedics Organ Care System (OCS) Heart System, including … has proposed the following Indications for Use: The TransMedics® Organ Care System (OCS™) Heart System is a …
GUDP July 14, 2021 FDA OCS Liver System - Presentation
… TransMedics® Organ Care System™ (OCS) Liver System FDA … Lauren J. Min, PhD 3 Proposed Indications for Use “The TransMedics® Organ Care System (OCS™) Liver is a portable … recipient." 4 OCS Liver Console OCS Liver Perfusion Set M TransMedics ! ~-_,. ~ ---- ' OCS Liver Bile Salts ij' 5odl~m …
GUDP July 14, 2021 Waiver Acknowledgment - Jennifer C. Lai, M.D., M.B.A.
… regarding a premarket approval application (PMA) for the TransMedics® Organ Care System (OCS™) - Liver by TransMedics, Inc., I may be considered for participation in …
GUDP July 14, 2021 Agenda
… regarding the premarket approval application (PMA) for the TransMedics® Organ Care System™ (OCS) Liver System 9:00 a.m. … Statement James Swink Designated Federal Officer 9:15 a.m. TransMedics® Presentation 10:45 a.m. Clarifying questions …
CSDP April 6, 2021 FDA Presentation
… TransMedics® Organ Care System™ (OCS) Heart System FDA … • Heart Solution Set 4 Proposed Indications for Use The TransMedics® Organ Care System (OCS™) Heart System is a … in predicted survival 34 3535 FDA Clinical Review TransMedics Organ Care System Heart System John S. …
GUDP July 14, 2021 Summary Minutes
… information related to the premarket application for the TransMedics Organ Care System (OCS) Liver System. PANEL … Hassanein, M.D., presented background information on the TransMedics Organ Care System. He addressed the limitations … that were not fully apparent in pre-preservation biopsies. TransMedics Positions on FDA Discussion Questions Dr. …
CSDP April 6, 2021 Summary Minutes
… information related to the premarket application for the TransMedics Organ Care System (OCS) Heart. PANEL … presentation and provided background information on TransMedics. He noted that only 30% of donor hearts are … not valid or reliable for extrapolation of long-term data. TransMedics Positions on FDA Questions and Training, and …
CSDP April 6, 2021 Panel Questions
… Questions for the Advisory Committee meeting for the TransMedics OCS Heart System for expanded criteria donor … for Use Proposed Indications for Use Statement: The TransMedics® Organ Care System (OCS™) Heart System is a …
GUDP July 14, 2021 Discussion Questions
… and Urology Devices Panel Advisory Committee Meeting on TransMedics® Organ Care System™ (OCS) Liver System July 14, …
CSDP April 6, 2021 Presentation - Panel Questions
… pool of available donor hearts. 16 Indications for Use The TransMedics® Organ Care System (OCS™) Heart System is a …
CSDP 2019 Curriculum Vitae James Blankenship
… and Late Mortality, June 19-20 2019 ---FDA Panel on Transmedics Organ Care System, April 6 2021 ---FDA Panel on …