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 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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IDE Approval means approval by the FDA that the Product received Investigational Device Exemption.
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Examples of IDE Approval in a sentence

  • 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.

  • 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.

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

  • Notwithstanding the foregoing, ▇▇▇▇▇ 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.

  • Buyer will (and will require that its Affiliates will) maintain complete and accurate records in sufficient detail to permit the Securityholder Representative to verify accurately whether Buyer has achieved the IDE Approval, the PMA Approval, the JPMDA Approval, the CNMPA Approval and the Additional Consideration Amount.

  • 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.

  • 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.

  • 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.

  • 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.


More Definitions of IDE Approval

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 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 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
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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.

  • 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 (a) at least a majority of the outstanding shares of Company Capital Stock, voting together as a single class and (b) at least a majority of the outstanding shares of Series A-1 Preferred Stock, Series B Preferred Stock and Series C Preferred Stock, voting together as a single class on an as-converted basis.

  • 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: