Premarket Notification definition

Premarket Notification means premarket 510(k) notification K140944 for the Phoenix Atherectomy System.
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Premarket Notification means premarket 510(k) notification K132978 for the clinical version of the MassARRAY® System, branded under the name IMPACT Dx System, and the Factor V Leiden and Factor II genotyping assay, as the same may be amended.
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Premarket Notification means the authority to sell a medical device in the United States granted by the FDA pursuant to 21 Code of Federal Regulations Section 807.81, as amended.
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Examples of Premarket Notification in a sentence

  • The JDT shall develop mutually agreeable budgets and schedules which will establish the maximum amount of Development Costs (such amount is referred to herein as the "Development Cost Limit") to be expended in developing the Clinical Test Inhaler and the Inhaler to the point of completion of an application for Section 510(k) Premarket Notification Clearance ("510(k) Clearance") for the Inhaler.

  • Wescor shall use its best efforts with all reasonable speed and efficiency to conduct and complete, or cause MicroCor to conduct and complete, such actions as are reasonably necessary to gather data and prepare a 510(k) Premarket Notification submission to the FDA covering the Product(s) and to obtain the necessary clearances from the FDA to market such Product(s) in the United States market ("FDA Clearance").

  • Any certification, regulatory approval or filings required (such as, but not limited to, site registration, device listing, medical device reporting, 510(k) Premarket Notification, and proof of adherence to Good Manufacturing Practices) are exclusively the responsibility of Customer.

  • STELKAST will use its best effort, using data existing as of the Effective Date, to assist MAKO in applying for and obtaining a Premarket Notification 510(k) and a CE marking for the Implant by providing MAKO with all required technical information and appropriate documentation within STELKAST’s possession or control, including, without limitation, clinical data, a complete copy of any regulatory filing for the Implant made by STELKAST and other relevant help at no additional charge.

  • Neither Eyegate nor any of its Affiliates has applied for or obtained a Premarket Approval (PMA) or a Premarket Notification 510(k) for the EyeGate® II Delivery System.

  • At any time following MAKO’s receipt of its own Premarket Notification 510(k) (a “MAKO 510(k)”), MAKO shall have the right (a) in its sole discretion, to choose the manufacturer of the System other than ENCORE at any time based on MAKO’s production needs and (b) to manufacture the System itself for use with the HGS using MAKO’s preferred suppliers as a MAKO product.

  • MAKO may sell Implants (whether purchased from STELKAST pursuant to the Supply Agreement or made by MAKO pursuant to this License Agreement) under STELKAST’s Premarket Notification 510(k) until MAKO receives a Premarket Notification 510(k).

  • MAKO will use its best effort to receive a Premarket Notification 510(k) as promptly as shall be reasonably practical after the Effective Date.

  • FDA environmental test requirements and test protocols specified by domestic and international standards contained within the Reviewer Guidance for Premarket Notification Submissions, November 1993.

  • Sample size is based upon the following:  Premarket Notification (510(k)) Guidance Document for Daily Wear Contact Lenses – at least 50 evaluable subjects to be followed for at least 3 months, for claim of substantial equivalence for a lens with different repeating monomer Units (new Parent USAN).