PMA Sample Clauses

PMA. Approval from the FDA to commercially distribute a medical device under the Pre Market Approval regulations.
Sample 1Sample 2Sample 3
AutoNDA by SimpleDocs
PMA. The term “
Sample 1Sample 2
PMA. The term "PMA" shall mean a Pre-Market Approval Application, 510(k) Application or any other application for regulatory approval of a device, and any supplement or abbreviated application relating thereto, submitted to the FDA (or the equivalent in any foreign country).
Sample 1
PMA. As a result of completing this project, we learned that the PMA Trade Show continues to be a very effective venue to make contact with buyers looking to buy Mississippi sweet potatoes. Sales of sweet potatoes increased above set goal. All goals and outcomes were achieved. Tip Rot Research: One of the lessons learned was that the sweet potato growers could reduce the loss to tip rot diseases if they would dip their transplants prior to planting in a recommended bio-fungicide. Another lesson learned was that timely and proper curing of potatoes after harvest helps to heal injuries incurred during the harvest process to the potato skin which then reduces postharvest rots. This research project shows that growers need to reduce the use of ethephon as a harvest aid under wet harvest conditions because it increases the incidence of Tip Rot in the stored potatoes. All of these lessons will be used to advise growers in the future on how to better manage tip rot in their sweet potatoes. Contact Person Xxxxx Xxxxxx 000-000-0000 xxxxx.xxxxxxxxx@xxxxx.xxx XXXXXX COUNTY YOUTH COURT H.A.R.V.E.S.T. PROJECT (HELPING ADOLESCENTS IN XXXXXX VALUE ENVIRONMENTAL SKILLS TODAY) Project Summary The purpose of this initiative was to create a hands-on learning opportunity related to the art and science of gardening for the youth who have become involved in the Xxxxxx County juvenile justice system by committing delinquent acts (i.e., acts that if they were committed by an adult would constitute a criminal offense). Because this was a brand new project, the youth were able to be involved in every aspect of creating the garden from designing the garden’s lay-out to harvesting the final products. Through this project the youth learned about creative expression, civic/community collaboration, healthy food, and sustainable living. The hope was that the project inspired some of the youth to pursue a career in growing their favorite specialty crop and provided them with the knowledge and skills to create a garden of their own, but at a minimum it helped them to make healthier decisions about the food they eat. The timeliness of this project coincided with Xxxxxx County completing a brand new, state-of-the-art juvenile detention facility in Pelahatchie, Mississippi with over six (6) acres of green space available which has now been transformed into an agricultural oasis. Various fruit trees were planted around the property, as well as small container gardens growing various specialty veget...
Sample 1
PMA. Attached hereto as Exhibit A is a full, complete and accurate copy of the PMA and there have not been any changes or amendments thereto which have not been provided to LaserSight in writing. The Company has made available to LaserSight all material correspondence, notices and other communications that the Company has received from the FDA in connection with the PMA and will deliver such items to LaserSight at the Closing. The PMA has been accepted for filing by the FDA.
Sample 1
PMA. Physician member’s professional fees – PMA volunteer members shall not charge AFP active members to include commissioned and enlisted personnel any professional fees in excess of Philippine Health Insurance Corporation coverage and/or other insurance coverage for treatment on the following terms and conditions:
Sample 1
PMA. In the event that Market Approval of the HIFU System in the U.S. shall require the filing and prosecution of a PMA with the FDA, UST shall have the right to terminate this Agreement in the event that Atricure shall not have filed a related IDE with the FDA on or before the Third Anniversary. In the event that UST shall have the right so to terminate this Agreement, such right shall be exercisable only by the giving of notice to Atricure to such effect, and such notice shall not be valid unless given on or before the date falling thirty (30) days after the Third Anniversary.
Sample 1
AutoNDA by SimpleDocs
PMA. Pre-market approval
Sample 1

Related to PMA

  • No Regulatory Approval By CenterState or Charter, if either of their respective boards of directors so determines by a vote of a majority of the members of its entire board, in the event any Regulatory Approval required for consummation of the transactions contemplated by this Agreement shall have been denied by final, non-appealable action by such Governmental Authority or an application therefor shall have been permanently withdrawn at the request of a Governmental Authority.

  • FDA As to each product subject to the jurisdiction of the U.S. Food and Drug Administration (“FDA”) under the Federal Food, Drug and Cosmetic Act, as amended, and the regulations thereunder (“FDCA”) that is manufactured, packaged, labeled, tested, distributed, sold, and/or marketed by the Company or any of its Subsidiaries (each such product, a “Pharmaceutical Product”), such Pharmaceutical Product is being manufactured, packaged, labeled, tested, distributed, sold and/or marketed by the Company in compliance with all applicable requirements under FDCA and similar laws, rules and regulations relating to registration, investigational use, premarket clearance, licensure, or application approval, good manufacturing practices, good laboratory practices, good clinical practices, product listing, quotas, labeling, advertising, record keeping and filing of reports, except where the failure to be in compliance would not have a Material Adverse Effect. There is no pending, completed or, to the Company's knowledge, threatened, action (including any lawsuit, arbitration, or legal or administrative or regulatory proceeding, charge, complaint, or investigation) against the Company or any of its Subsidiaries, and none of the Company or any of its Subsidiaries has received any notice, warning letter or other communication from the FDA or any other governmental entity, which (i) contests the premarket clearance, licensure, registration, or approval of, the uses of, the distribution of, the manufacturing or packaging of, the testing of, the sale of, or the labeling and promotion of any Pharmaceutical Product, (ii) withdraws its approval of, requests the recall, suspension, or seizure of, or withdraws or orders the withdrawal of advertising or sales promotional materials relating to, any Pharmaceutical Product, (iii) imposes a clinical hold on any clinical investigation by the Company or any of its Subsidiaries, (iv) enjoins production at any facility of the Company or any of its Subsidiaries, (v) enters or proposes to enter into a consent decree of permanent injunction with the Company or any of its Subsidiaries, or (vi) otherwise alleges any violation of any laws, rules or regulations by the Company or any of its Subsidiaries, and which, either individually or in the aggregate, would have a Material Adverse Effect. The properties, business and operations of the Company have been and are being conducted in all material respects in accordance with all applicable laws, rules and regulations of the FDA. The Company has not been informed by the FDA that the FDA will prohibit the marketing, sale, license or use in the United States of any product proposed to be developed, produced or marketed by the Company nor has the FDA expressed any concern as to approving or clearing for marketing any product being developed or proposed to be developed by the Company.

  • Regulatory Approval 25.1 The Parties understand and agree that this Agreement and any amendment or modification hereto will be filed with the Commission for approval in accordance with Section 252 of the Act and may thereafter be filed with the FCC. The Parties believe in good faith and agree that the services to be provided under this Agreement are in the public interest. Each Party covenants and agrees to fully support approval of this Agreement by the Commission or the FCC under Section 252 of the Act without modification.

  • Requisite Regulatory Approvals All Consents required to be obtained from or made with any Governmental Authority in order to consummate the transactions contemplated by this Agreement shall have been obtained or made.

  • Medication 1. Xxxxxxx’s physician shall prescribe and monitor adequate dosage levels for each Client.

  • Supplier Diversity Seller shall comply with Xxxxx’s Supplier Diversity Program in accordance with Appendix V.

  • Xxxxxx and Recall An employee in receipt of notice of layoff pursuant to 9.08(A)(a)(ii) may:

  • Other Regulatory Approvals Each party hereto shall cooperate and use its reasonable best efforts to promptly prepare and file all necessary documentation to effect all necessary applications, notices, petitions, filings and other documents, and use all reasonable efforts to obtain (and will cooperate with each other in obtaining) any consent, acquiescence, authorization, order or approval of, or any exemption or nonopposition by, any Governmental Entity required to be obtained or made by Parent or the Company or any of their respective Subsidiaries in connection with the Offer and the Merger or the taking of any other action contemplated by this Agreement.

  • Product Recall (a) If a recall is required by applicable Law, or if Buyer or Supplier reasonably determines that a recall is advisable because the goods may create a potential safety hazard, are not in compliance with any applicable code, standard or legal requirement, or contain a defect or non-conformance with the requirements of this Order occurring or likely to occur in multiple goods, which such defects or non-conformances are substantially similar or have substantially similar causes or effects (collectively a “Serial Defect”), the parties shall promptly communicate such facts to each other. At Buyer’s request, Supplier shall promptly develop a corrective action plan satisfactory to Buyer, which shall include all actions required to recall and/or repair the goods and any actions required by applicable Law (“Corrective Action Plan”) for Buyer’s review and approval. At Buyer’s election, Xxxxx may develop the Corrective Action Plan. In no event shall Buyer and Supplier’s failure to agree on the Corrective Action Plan delay the timely notification of a potential safety hazard, non-compliance or Serial Defect to users of the goods, cause either party to be non-compliant with applicable Law or prevent Buyer from taking reasonable actions to prevent injury or damage to persons, equipment or other property. Supplier and Buyer shall cooperate with and assist each other in any corrective actions and/or filings, if applicable.

  • Regulatory Approvals All Requisite Regulatory Approvals shall have been obtained and shall remain in full force and effect and all statutory waiting periods in respect thereof shall have expired, and no such Requisite Regulatory Approval shall have resulted in the imposition of any Materially Burdensome Regulatory Condition.

Time is Money Join Law Insider Premium to draft better contracts faster.