IDE Approval definition

IDE Approval means approval of the Assay by the FDA of an Investigational Device Exemption.
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IDE Approval means approval by the FDA that the Product received Investigational Device Exemption.
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IDE Approval means FDA's approval of an IDE Application or an IDE deemed approved pursuant to the requirements set forth in 21 C.F.R. Part 812 permitting distribution of an investigational product.
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Examples of IDE Approval in a sentence

  • Ark shall perform analytical Verification studies of the Assay to support IDE Approval, and shall timely provide all necessary information and materials and provide other cooperation reasonably required for the IDE preparation, submission, and Approval, including without limitation, those responsibilities allocated to Ark as set forth in the SOW.

  • None of the Banner Companies have received any written notices, correspondence or other communication from an Institutional Review Board, ethics committee, the FDA or any other Governmental Authority withdrawing IND or IDE Approval or requiring the termination, suspension or modification of any clinical, pre-clinical, or other studies or tests.

  • The Securityholder Representative shall have an opportunity to ask certain Representatives of Buyer reasonably designated by Buyer questions regarding, and to discuss with such Representatives, at reasonably agreed times during normal business hours, the then status of progress to obtain the IDE Approval, the PMA Approval, the JPMDA Approval, and the CNMPA Approval and the then status of the sales of the Solution and revenues generated in connection with such sales.

  • Notwithstanding the foregoing, Xxxxx agrees and covenants that Buyer, its Affiliates or anyone on their behalf, shall not take, and that they shall not permit any third party to take, any actions in bad faith in their performance of the Business or otherwise, which are intentionally undertaken with the express purpose of, and have the actual effect of preventing the First IDE Approval Milestone or the Second IDE Approval Milestone.

  • For purposes of this paragraph," Extended BSC PMA Filing Date" means the date which is twenty-four (24) months following the BSC IDE Approval Date plus the number of months of required clinical follow-up in excess of nine (9) months.

  • For purposes of this paragraph, "Extended Cook PMA Filing Date" means the date which is twenty-four (24) months xxxlowing the Cook IDE Approval Date plus the number of months the FDA requires clixxxxl follow-up in excess of nine (9) months.

  • For purposes of clarification, in no event shall Buyer be obligated to pay the IDE Approval Cash Consideration or issue the IDE Approval Stock Consideration more than once or make more than one PMA Approval Payment, more than one JPMDA Approval Payment or more than one CNMPA Approval Payment.

  • Structural Heart Studies: 6 • Average IDE Approval Time = 38 days• Close Sponsor-Investigator-FDA CollaborationSource: MDIC Survey of EFS Structural Heart Sponsor Participants – Results as of 6/9/2017II.

  • The issuance of the shares of Buyer Common Stock comprising the IDE Approval Stock Consideration, if and when issued in accordance with the terms of this Agreement, will be duly and validly issued, fully paid and non-assessable and shall not be subject to preemptive or similar rights.

  • Any notice required or permitted under this Agreement shall be in writing and shall become effective on the day of mailing thereof by first class mail, or certified mail, postage prepaid addressed:If to the COLLEGE: Douglas OlsonVice President, Academic and Student AffairsTriton College 2000 Fifth AvenueRiver Grove, Illinois 60171 cc: Sarie E.


More Definitions of IDE Approval

IDE Approval means the FDA has approved the IDE Application such that Buyer may initiate the PMA US Pivotal Study protocol set forth in the IDE Application subject to compliance with the following requirements: (a) labeling according to 21 CFR 812.5; (b) distribution according to 21 CFR 812.43(b); (c) informed consent according to 21 CFR 50; (d) monitoring according to 21 CFR 812.46; (e) prohibitions according to 21 CFR 812.7; and (f) records and reports according to 21 CFR 812.140 and 21 CFR 812.150.
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IDE Approval means approval of an investigational device exemption application filed with the United States Food and Drug Administration, or the equivalent regulatory approval in Japan, Canada or any western European country.
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IDE Approval means the receipt of an FDA Letter stating that a Product has achieved unconditional pivotal FDA Investigational Device Exemption approval (i.e., “full approval”) that enables the conduct of a pivotal clinical trial: (a) with respect to the PTCA-DCB Product, for coronary use of the PTCA-DCB Product that is designed to achieve Premarket Approval Application approval for a coronary use with an in stent restenosis indication; and/or (b) with respect to the PTA-DCB Product, for use in superficial femoral artery of the PTA-DCB that is designed to achieve Premarket Approval Application approval for an SFA indication.
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IDE Approval shall have the meaning set forth in the Development Agreement.
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IDE Approval means the FDA has approved the IDE Application such that Buyer may initiate the PMA US Pivotal Study protocol set forth in the IDE Application subject to compliance with the following requirements: (a) labeling according to 21 CFR 812.5; (b) distribution according to 21 CFR 812.43(b); (c) informed consent according to 21 CFR 50; (d) monitoring according to 21 CFR 812.46; (e) prohibitions according to 21 CFR 812.7; and(f) records and reports according to 21 CFR 812.140 and 21 CFR 812.150.
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Related to IDE Approval

  • Pre-approval means written notification via a pre-approval letter to Customer that Ameren Illinois has reviewed Customer's Application and determined that the project meets the program eligibility requirements for a maximum pre-approved incentive amount if the project is completed by the estimated completion date and all final application paperwork is submitted and approved.

  • IRB approval means the determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and federal requirements.

  • Price Approval means, in any country where a Governmental Authority authorizes reimbursement for, or approves or determines pricing for, pharmaceutical products, receipt (or, if required to make such authorization, approval or determination effective, publication) of such reimbursement authorization or pricing approval or determination (as the case may be).

  • type-approval means the procedure whereby an approval authority certifies that a type of vehicle, system, component or separate technical unit satisfies the relevant administrative provisions and technical requirements;

  • Requisite Approval means the affirmative vote of the holders of at least a majority of the shares of outstanding Company Common Stock and outstanding Company Preferred Stock voting as a single class.

  • CPUC Approval means a final and non-appealable order of the CPUC, without conditions or modifications unacceptable to the Parties, or either of them, which contains the following terms:

  • HSR Approval means expiration of all applicable waiting periods under the HSR Act (including any voluntary agreed extensions) or earlier termination thereof.

  • CFIUS Approval means that any of the following shall have occurred: (a) the review period under the DPA commencing on the date that a CFIUS Notice is accepted by CFIUS shall have expired and Xxx, on the one hand, and Polaris, on the other hand, shall have received written notice from CFIUS to the effect that such review has been concluded and that either the Contemplated Transactions do not constitute a “covered transaction” under the DPA or there are no unresolved national security concerns, and all action under the DPA is concluded with respect to the Contemplated Transactions, (b) an investigation under the DPA shall have been commenced after such review period and CFIUS shall have determined to conclude all action under the DPA without sending a report to the President of the United States, and Xxx, on the one hand, and Polaris, on the other hand, shall have received written notice from CFIUS that either the Contemplated Transactions do not constitute a “covered transaction” under the DPA or there are no unresolved national security concerns, and all action under the DPA is concluded with respect to the Contemplated Transactions, or (c) CFIUS shall have sent a report to the President of the United States requesting the President’s decision and either (i) the President shall have announced a decision not to take any action to suspend or prohibit the Contemplated Transactions or, (ii) the period under the DPA during which the President may announce his decision to take action to suspend, prohibit or place any limitations on the Contemplated Transactions shall have expired without any such action being threatened, announced or taken.

  • FCC Approval means the FCC’s grant of the FCC Applications, including any grants by operation of law; provided that the possibility that an appeal, request for stay, or petition for rehearing or review by a court or administrative agency may be filed with respect to such grant, or that the FCC may reconsider or review such grant on its own authority, shall not prevent such grant from constituting FCC Approval for purposes of the Plan.

  • MAA Approval means approval of an MAA by the applicable Regulatory Authority for marketing and sale of a Product in the Collaborator Territory, but excluding any Pricing and Reimbursement Approval.

  • Approval means the written consent of the Authority.

  • Prior Approval means written ap- proval by an authorized official evi- dencing prior consent.

  • Special Approval means approval by a majority of the members of the Conflicts Committee.

  • Requisite Shareholder Approval means the affirmative vote of a majority of the outstanding shares of the Company’s Voting Stock (voting together as a single class) and the affirmative vote of a majority of the outstanding shares of Common Stock (voting separately as a single class), in each case approving the amendment of the Company’s amended and restated articles of incorporation to increase the number of authorized shares of Common Stock to 150,000,000 shares.

  • Shareholder Approval Date means the date on which this Plan is approved shareholders of the Company eligible to vote in the election of directors, by a vote sufficient to meet the requirements of Code Sections 162(m) (if applicable) and 422, Rule 16b-3 under the Exchange Act (if applicable), applicable requirements under the rules of any stock exchange or automated quotation system on which the Shares may be listed on quoted, and other laws, regulations and obligations of the Company applicable to the Plan.

  • Shareholder Approval means such approval as may be required by the applicable rules and regulations of the Nasdaq Stock Market (or any successor entity) from the shareholders of the Company with respect to the transactions contemplated by the Transaction Documents, including the issuance of all of the Underlying Shares in excess of 19.99% of the issued and outstanding Common Stock on the Closing Date.

  • Initial approval means authorization to admit students and enter into contractual agreements for clinical facilities. It is granted only after an application has been submitted, reviewed and a survey visit made by the Board. No students shall be admitted to the program until the institution has received written notification that initial approval has been granted. Failure to comply will delay initial approval.

  • NDA Approval means the Approval of an NDA by the FDA for a Product in the U.S.

  • Required Shareholder Approval has the meaning in Section 2.20.

  • Works Approval means this Works Approval numbered W5914/2015/1 and issued under the Act; and

  • Board Approval means the affirmative vote of a majority of the Disinterested Directors of the Company or a unanimous written consent of the Board of Directors of the Company duly obtained in accordance with the applicable provisions of the Company's certificate of incorporation, bylaws and applicable law.

  • Authorized Share Approval means approval of the Amendment by the shareholders of the Company.

  • Government Approval means any authorization, consent, approval, waiver, exception, variance, order, exemption, publication, filing, declaration, concession, grant, franchise, agreement, permission, permit, or license of, from or with any Governmental Authority, the giving notice to, or registration with, any Governmental Authority or any other action in respect of any Governmental Authority.

  • Conditional approval means a time-limited status that results when an approved nursing education program has failed to maintain requirements as set forth in this chapter.

  • Approval Authority means the authority of a Member State with competence for all aspects of the approval of a type of vehicle, system, component or separate technical unit or of the individual approval of a vehicle; for the authorisation process, for issuing and, if appropriate, withdrawing approval certificates; for acting as the contact point for the approval authorities of other Member States; for designating the technical services and for ensuring that the manufacturer meets his obligations regarding the conformity of production;

  • Application Approval Date means the date that the Application is approved by the Board of Trustees of the District and as further identified in Section 2.3.B of this Agreement.