PMA Letter definition

PMA Letter means a letter issued by the United States Food and Drug Administration (“FDA”) which grants clearance or premarket approval for the sale of the Pipeline device in the United States with an indication to treat any subset of intracranial aneurysms, provided that such letter does not impose material restrictions that severely diminish the long term commercial viability of the Pipeline device in the United States, it being understood that none of the following conditions contained in the letter will be deemed to severely diminish the long term commercial viability of the Pipeline device in the United States: (a) the standard conditions (Conditions of Approval) found in all medical device premarket approval and 510(k) clearance letters, as the case may be, issued by the FDA, (b) warnings, cautions, precautions and contraindications that are customary or reasonable given the nature and purpose of the Pipeline device that don’t otherwise, individually or in the aggregate, severely diminish the long term commercial viability of the Pipeline device in the United States, (c) a requirement that a post approval study be conducted on the Pipeline device, (d) a requirement that physicians who will be working with the Pipeline device receive reasonable training with respect to the device, or (e) a requirement that only physicians with expertise in neurovascular procedures use the device. In the event that the FDA issues a letter which does not satisfy the definition of PMA Letter above, then the obligations of the parties under this Agreement to continue to attempt to obtain the PMA Letter shall continue in accordance with the terms of this Agreement.
Sample 1

Examples of PMA Letter in a sentence

  • Sample PMA Letter of Application The ABC Tool Company 3000 Hill St.Randolph, MA 02368(781) 555-1212 FAA - New England Region12 New England Executive Park Burlington, MA 01803(781) 238-7199 Attention: Mr. Mark StealeManager, Boston Manufacturing Inspection District Office, ANE-MIDO-42 Subject: Request for New FAA-PMA Approval Mr. Steale:The ABC Tool Company is submitting an application for Parts Manufacturer Approval for our part number (P/N) ABC 13579.

  • The November 4, 2002 PMA Letter is referenced in the Complaint and is a matter of public record and, thus, we can consider it on a Motion for Judgment on the Pleadings.

  • Mr Nutt and Mr Tan discussed the fact that Marex would be selling nickel to Natixis and delivering warehouse receipts to it (Access World had also issued the PMA Letter to Natixis on 14 November).

  • An SFHA may also include an area re-designated by FEMA approval of a calculated revision request based on new or revised scientific or technical data in the form of a Physical Map Revision (PMA), Letter of Map Revision (LOMR), or a Letter of Map Change (LOMC).

  • The only conduct described in the THA MACC is a conclusory reference to “violations of the PMA Letter for the BHR cup, and the 510(k) approval order for the various other components including the MFH.” THA MACC ¶ 351; id.

  • The Authorized party (i.e. sponsor-investigator) should include a copy of the 510(k) or PMA Letter of Authorization in the IDE application and reference same in the appropriate application sections.

  • PMA Letter & Data ACOEvaluate Design DataMIDOEvaluate Quality System and Conformity Issue PMANo Figure A-2.

  • From and after the Effective Time, the Surviving Corporation will manage its overall ongoing business as it determines reasonably necessary to pursue and obtain the issuance of the PMA Letter.

Related to PMA Letter

  • Contract Letter means the letter identifying those documents which form the Contract.

  • Post Closing Letter is that certain Post Closing Letter dated as of the Effective Date by and between Collateral Agent and Borrower.

  • Confirmation Letter means a letter issued by any applicable Rating Agency to the effect that neither (a) the resignation of Provident as Servicer under the Servicing Agreement and appointment of Litton as successor Servicer thereunder, nor (b) the amendments exxxxxxated by this Agreement, will adversely affect the then current ratings on the Certificates then being rated.

  • Mandate Letter has the meaning ascribed to it in the Memorandum of Understanding between MOHLTC and the LHIN, and means a letter from the Minister to the LHIN establishing priorities in accordance with the Premier’s mandate letter to the Minister.

  • Investment Letter shall have the meaning specified in subsection 9.07(a).

  • Advisory letter means a nondisciplinary letter to notify a

  • Undertaking Letter The letter in substantially the form set forth in Exhibit C of the Trust Agreement.

  • Disbursement Letter means an instructional letter executed and delivered by Borrower to Agent regarding the extensions of credit to be made on the Closing Date, the form and substance of which is satisfactory to Agent.

  • Welcome Letter means the document entitled “welcome letter” containing important details about this group policy;

  • Investor Letter means that certain Investor Letter, substantially in the form attached hereto as Exhibit B.

  • Escrow Agreement means the escrow agreement entered into prior to the date hereof, by and among the Company, the Escrow Agent and the Placement Agent pursuant to which the Purchasers shall deposit Subscription Amounts with the Escrow Agent to be applied to the transactions contemplated hereunder.

  • Master Separation Agreement has the meaning set forth in the recitals.

  • Sponsor Letter Agreement has the meaning set forth in the recitals to this Agreement.

  • Closing Escrow Agreement means the Closing Escrow Agreement, dated as of the date hereof, between the Company, Xxxx Capital Partners, LLC and the escrow agent (the “Escrow Agent”) identified therein, in the form of Exhibit B hereto.

  • Control Letter means a letter agreement between Agent and (i) the issuer of uncertificated securities with respect to uncertificated securities in the name of any Credit Party, (ii) a securities intermediary with respect to securities, whether certificated or uncertificated, securities entitlements and other financial assets held in a securities account in the name of any Credit Party, (iii) a futures commission merchant or clearing house, as applicable, with respect to commodity accounts and commodity contracts held by any Credit Party, whereby, among other things, the issuer, securities intermediary or futures commission merchant disclaims any security interest in the applicable financial assets, acknowledges the Lien of Agent, on behalf of itself and Lenders, on such financial assets, and agrees to follow the instructions or entitlement orders of Agent without further consent by the affected Credit Party.

  • Xxxxxx Agreement means that certain Contingent Stock Agreement, effective as of January 1, 1996, by The Xxxxx Company in favor of and for the benefit of the Holders (named in Schedule I thereto) and the Representatives (therein defined), as amended.

  • Transition Agreement means the Transition Power Sales Agreement dated as of November 24, 1998, by and between Seller, Southern Energy, Southern Energy Bowline, L.L.C. and Southern Energy Xxxxxx, L.L.C.

  • Commitment Letter has the meaning set forth in Section 5.7.

  • Estoppel Letter A document executed by the Cooperative Corporation certifying, with respect to a Cooperative Unit, (i) the appurtenant Proprietary Lease will be in full force and effect as of the date of issuance thereof, (ii) the related stock certificate was registered in the Mortgagor's name and the Cooperative Corporation has not been notified of any lien upon, pledge of, levy of execution on or disposition of such stock certificate, and (iii) the Mortgagor is not in default under the appurtenant Proprietary Lease and all charges due the Cooperative Corporation have been paid.

  • Engagement Letter means that certain Engagement Letter, dated as of June 18, 2015, by and among the Borrower and the Arrangers.

  • Representation Letter Letters to, or agreements with, the Depository to effectuate a book entry system with respect to the Class A Certificates registered in the Register under the nominee name of the Depository.

  • Post-Closing Agreement shall have the meaning set forth in Section 8.9.

  • SCM Agreement means the Agreement on Subsidies and Countervailing Measures, contained in Annex 1A to the WTO Agreement;

  • Disbursement Agreement means the Master Disbursement Agreement, dated as of the Closing Date, by and among the Administrative Agent, the Bank Facilities Administrative Agent, the Disbursement Agent, the Borrowers and LCR, in substantially the form of Exhibit D-3 hereto, as the same may be amended, supplemented, amended and restated, or otherwise modified in accordance with the terms hereof and thereof.

  • Termination Letter has the meaning specified in Section 2.17(b).

  • Disbursement Instruction Agreement means an agreement substantially in the form of Exhibit B to be executed and delivered by the Borrower pursuant to Section 6.1.(a), as the same may be amended, restated or modified from time to time with the prior written approval of the Administrative Agent.