investigational device definition
investigational device means any device being assessed for safety and/or performance in a clinical investigation;
investigational device means a device that is assessed in a clinical investigation;
investigational device means a device that:
More Definitions of investigational device
investigational device means a device that has been assessed in a clinical trial;
investigational device means a device, including a transitional device that is the object of a clinical investigation or Research involving one or more Human Subjects to determine the safety and/or effectiveness of a device.
investigational device. The BioCardia® CardiAMP™ System, consisting of the CardiAMP cell separator and autologous bone marrow mononuclear cells delivered using the Helix transendocardial delivery catheter Sponsor: BioCardia, Inc. ▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇ ▇▇▇▇▇ ▇ ▇▇▇ ▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇
investigational device means a device that is assessed in a clinical investigation; (47)‘clinical investigation plan’ means a document that describes the rationale, objectives,
investigational device. The BioCardia® CardiAMP™ System, consisting of the CardiAMP cell separator and autologous bone marrow mononuclear cells delivered using the Helix transendocardial delivery catheter Sponsor: BioCardia, Inc. ▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇ ▇▇▇▇▇ ▇ ▇▇▇ ▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇ Consultant: As a Steering Committee (SC) consultant for the Study, I certify that I, my spouse or dependent children (check the appropriate box for each statement): [ ] Have [ X ] Do not have Have an ownership interest, stock options, or other financial interest (i.e., equity interest) in the Sponsor (public or non-public) that owns the Investigational Device being evaluated in the Study. [ ] Have [ X ] Do not have Have property or other financial interest (i.e., proprietary interest) in the Investigational Device being evaluated in the Study; including, but not limited to, a patent or patent interest, trademark, copyright, licensing agreement, or any arrangement tied to a current or future right to receive royalties associated with the development or eventual commercialization of the Investigational Device. [ ] Have [X ] Do not have Receive payments from the Sponsor that owns the respective Investigational Device during the term of the conduct of the Study; nor do I anticipate receiving payments from the Sponsor during a 1 year period following completion of the Study. Applicable payments (i.e., financial interest) include, but are not limited to, grants to fund projects or research or compensation in the form of monetary payments, equipment, or retainers for consultation or honoraria. Name of Consultant (Printed or Typed) /s/ ▇▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇ 2/15/2021 Signature of Consultant Date BioCardia CardiAMP Study Steering Committee Consulting Agr ▇▇. ▇▇▇▇ ▇▇▇▇▇▇▇ Title of Clinical Study: Randomized Controlled Pivotal Trial of Autologous Bone Marrow Mononuclear Cells Using the CardiAMP System in Patients with Post Myocardial Infarction Heart Failure (CardiAMP Heart Failure Trial)
investigational device means a device that is assessed in a clinical investigation; c) Araştırma amaçlı cihaz: Bir klinik araştırma kapsamında değerlendirilmekte olan cihazı,