PMA Approval definition

PMA Approval means approval from the FDA of a PMA Application.

PMA Approval means approval of a Premarket Approval (PMA) Application in accordance with Section 515 of the FFDCA and 21 C.F.R. Part 814, each as amended from time to time, of a PMA by the FDA for a Class III device or similar approval in other countries or regulatory jurisdictions.

PMA Approval means pre-market approval in the United States, as defined in 21 U.S.C. §360(e) of the United States Code, of a Companion Diagnostic incorporating a Program Biomarker.

Examples of PMA Approval in a sentence

• The Parties desire and intend to collaborate with respect to the development, validation and PMA Approval of the Companion Diagnostic on the terms and conditions set forth in this Agreement.

• The JCDC shall dissolve and cease to exist upon the earlier of: (i) the date mutually agreed by the Parties for such dissolution and cessation or (ii) PMA Approval.

• PMA Approval INFUSE™ Bone Graft/LT-CAGE™ Lumbar Tapered Fusion Device.

• Truman’s opinions that Smith & Nephew “failed to comply with BHR PMA Approval Letter Requirements” and violated the “Safe Medical Devices Act in the commercial distribution of the BHR,” if offered without the more specific context provided in the report, would not merely embrace the ultimate issue—they would consume it.

• It is intended that the Parties will utilize Genoptix’s expertise in developing medical laboratory tests, as well as the genotyping data generated by Genoptix or supplied by Ambit and patient samples collected by or on behalf of Ambit during the AC220-002 and AC220-003 Clinical Trials, to further develop and validate the ***Confidential Treatment Requested Assay as a Companion Diagnostic and to seek PMA Approval for the Companion Diagnostic to support the approval of the NDA for AC220.

More Definitions of PMA Approval

PMA Approval means the receipt by Parent or the Surviving Corporation of such notice.

PMA Approval means the authority to sell a medical device in the United States granted by the FDA pursuant to 21 Code of Federal Regulations Part 814, as amended.

PMA Approval means written approval by the FDA of a Premarket Approval application submitted for the AMDS (including any modifications of the AMDS reflected in the submission for such Regulatory Approval) with respect to the Field of Use.

PMA Approval means the approval of the PMA by the FDA with a claim or indication for use in surgical procedures as an adjunctive hemostatic device for arteriolar, capillary, or venular bleeding for the Products that includes PerClot Laparoscopic use/technique language in the instructions for use (IFU).

PMA Approval means the receipt by Senseonics or its affiliate or licensee of final approval from the FDA with respect to the PMA Submission (as defined below) to commercially distribute the 180-day Eversense XL in the United States (i) without conditions, (ii) without conditions materially more restrictive than those placed on the 90-day Eversense Product in the United States or (iii) with customary conditions that would not reasonably be expected to materially affect the ability of Senseonics, its affiliate or licensee, as applicable, to commercialize or maintain market authorization of such Product in the United States.

PMA Approval means receipt by the Company of a written communication ------------ from the United States Food & Drug Administration granting approval to begin commercial distribution of the Vascular Solutions Duett sealing device in the United States.

PMA Approval means approval by the health authorities to ------------ manufacture and sell Product in a country in the Territory; such approval intended to correspond to a Pre-Marketing Approval of a device or a New Drug Approval by the FDA. In the EU countries, the approval process includes the setting of a reimbursement price.