Pre-Market Approval definition

Pre-Market Approval means the scientific and regulatory review of a commodity, by the regulatory agency responsible for enforcing standards to which that commodity is subject, in order to establish that commodity’s safety and effectiveness before its approval for the market;
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Pre-Market Approval. (“PMA”) validation of Ablatherm by the American “Food and Drug Administration” (“FDA”) and acquisition by HT Prostate Therapy Management Company L.L.C. or any other HealthTronics Company (such as this term is defined in paragraph 10 below) lithotriteurs: • Shares A will be exercisable, within the scope of work by HT Prostate Therapy Management Company L.L.C. of clinical trials for Ablatherm, as from the date of the last follow-up of the last patient of the clinical trial Ablatherm led by HT Prostate Therapy Management Company L.L.C., within the framework of a “IDE” (“Investigational Device Exemption”). It is understood by “last follow-up of the last patient” that this is the last evaluation such as defined in the protocol of the test concerned for constitution of the clinical file of first tender of PMA; • Shares B will be exercisable from the tender by HT Prostate Therapy Management Company L.L.C. with the FDA filing of the homologation PMA (“Pre-Market Approval Application”) relating to Ablatherm, complete, in final form and in conformity with the requirements of the FDA; • Shares C will be exercisable at their issue, [HT Prostate Therapy Management Company L.L.C.] [or, if necessary: [•] [ name of the HealthTronics company carrying out the purchase], having purchased along with the company and its subsidiaries [indicate, if necessary, the company or the subsidiary of the company that HT Prostate bought lithotriteurs from during 2004] more than four (4) lithotriteurs during 2004, • Shares D will be exercisable as of January 1, 2006 in the event of the purchase of the Company or its subsidiaries, by HT Prostate Therapy Management Company L.L.C. or any other HealthTronics Company, of at least four (4) lithotriteurs during 2005, • Shares E will be exercisable as of January 1, 2007 in the event of the purchase of the Company or its subsidiaries, by HT Prostate Therapy Management Company L.L.C. or any other HealthTronics Company, of at least four (4) lithotriteurs during 2006, • Shares F will be exercisable as of January 1, 2008 in the event of the purchase of the Company or its subsidiaries, by HT Prostate Therapy Management Company L.L.C. or any other HealthTronics Company, of at least four (4) lithotriteurs during 2007, • Shares G will be exercisable from the receipt by HT Prostate Therapy Management Company L.L.C. written confirmation from the FDA of final receipt of the a valid PMA (“Pre-Market Approval”) for Ablatherm. In any event, and in accordance wit...
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Pre-Market Approval means the scientific and regulatory review o f a com m odity, by the regulatory agency responsible for enforcing standards to w hich th at commodity is subject, in order to establish that commodity’s safety and effectiveness before its approval for the market;
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Examples of Pre-Market Approval in a sentence

  • Neither FDA Pre-Market Approval nor FDA finding of substantial equivalency under 510(k) automatically guarantees coverage of a drug or device.

  • We are obligated to make the following milestone payments to UCLA TDG for each Licensed Product or Licensed Method: ● $100,000 upon enrollment of the first subject in a Feasibility Study; ● $250,000 upon enrollment of the first subject in a Pivotal Study: ● $500,000 upon Pre-Market Approval of a Licensed Product or Licensed Method; and ● $1,000,000 upon the First Commercial Sale of a Licensed Product or Licensed Method.

  • U.S. Food and Drug Administration (FDA): PreMarket Approval (PMA) No. P910066/S11.

  • Class III medical devices, like the devices at issue in this case, are the most highly-regulated class, and are intended for use in supporting or sustaining life, are of substantial importance in preventing impairment of health, or present a potential unreasonable risk of illness or injury.Generally, Class III medical devices may not be marketed in the United States without FDA approval of a Pre-Market Approval (“PMA”) application submitted by the device manufacturer.

  • We are obligated to make the following milestone payments to UCLA for each Licensed Product or Licensed Method: ● $100,000 upon enrollment of the first subject in a Feasibility Study; ● $250,000 upon enrollment of the first subject in a Pivotal Study: ● $500,000 upon Pre-Market Approval of a Licensed Product or Licensed Method; and ● $1,000,000 upon the First Commercial Sale of a Licensed Product or Licensed Method.

  • GenomeWeb Daily News, FDA Questions Whether Genomic Health Should Have Obtained Pre-Market Approval, January 30, 2006, http://genomeweb.com.

  • WSIADA asked for dealers to come and testify to the house committee, and then it died.

  • LICENSEE will file with the U.S. Food and Drug Administration at least one 510k Application or PMA (Pre-Market Approval) for clearance of Licensed Products for at least teletherapy uses within one (1) year of the Effective Date.

  • The Company's products, where required, are being marketed under valid 510(k) or Pre-Market Approval Applications.

  • The PreMarket Approval process requires, inter alia, performance of clinical trials at a larger scale, which may prolong the time period until receipt of regulatory approvals, and may increase the costs required to receive them.


More Definitions of Pre-Market Approval

Pre-Market Approval means receipt of written notification from the FDA of PMA (Pre-Market Application) approval and authorizing the commercial distribution of PLAATO in the United States;
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Pre-Market Approval means, in the United States, a Premarket Approval Application (PMA), Investigational New Drug Application (IND), New Drug Application (NDA) or Biologic License Application (BLA) under the United States Federal Food, Drug and Cosmetic Act and the regulations promulgated thereunder, all as amended, and in any jurisdiction outside the United States, a substantial equivalent to any of the foregoing applicable to such jurisdiction. For further clarification, the definition of Pre-Market Approval shall not include a 510(k) application in the United States or its foreign equivalent.
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Pre-Market Approval means the FDA approval of the PMA Application.
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Related to Pre-Market Approval

  • 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:

  • 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.

  • 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.

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

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

  • Product Approval means the approval of a Governmental Authority necessary for the marketing and sale of the Product in a given country or regulatory jurisdiction, which may include the approval of an MAA (but shall not include any Pricing Approvals).

  • Marketing Approval means all approvals, licenses, registrations or authorizations of the Regulatory Authority in a country, necessary for the manufacture, use, storage, import, marketing and sale of a Product in such country.

  • Pricing Approval means any approval, agreement, determination, or decision establishing prices that can be charged to consumers for a pharmaceutical or biological product or that will be reimbursed by Governmental Authorities for a pharmaceutical or biological product, in each case, in a country where Governmental Authorities approve or determine pricing for pharmaceutical or biological products for reimbursement or otherwise.

  • FCC Approval means the FCC’s grant of the FCC Applications; 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.

  • 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.

  • 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.

  • FDA Approval means the approval by the FDA of a premarket approval application to market and sell a Product, as evidenced by the publication of such approval by the FDA.

  • 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).

  • 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.

  • Regulatory Approval means any approval or clearance by any governmental agency or agencies having authority to regulate the use or sale of any Licensed Product(s) in the pertinent jurisdiction or territory.

  • Required Regulatory Approvals means the Seller Required Regulatory Approvals and the Buyer Required Regulatory Approvals.

  • 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.

  • 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.

  • Stockholder Approval Date means the date on which Stockholder Approval is received and deemed effective under Delaware law.

  • Requisite Regulatory Approvals has the meaning set forth in Section 7.01(b).

  • Approval Date means the date on which the Plan is approved by the Company’s stockholders.

  • Board Approval has the meaning set out in Section 2.2(a)(ii);

  • Marketing Authorization means all approvals from the relevant Regulatory Authority necessary to market and sell a Product in any country (including without limitation, all applicable pricing and governmental reimbursement approvals even if not legally required to sell Product in a country).

  • Competition Act Approval means that the Commissioner: (a) shall have issued an ARC, or (b) the applicable waiting period under section 123 of the Competition Act shall have expired or been terminated by the Commissioner, or the obligation to submit a notification shall have been waived under paragraph 113(c) of the Competition Act, and the Commissioner shall have issued a No-Action Letter;

  • Marketing Approval Application or “MAA” means a New Drug Application (or its equivalent), as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding or similar application, registration or certification in any country.

  • Marketing Authorization Application or “MAA” means an application for Regulatory Approval in a country, territory or possession.