PMA definition
Examples of PMA in a sentence
Except as otherwise provided herein, the PMA Responsible Party will be responsible for all medical device reporting, correction and removal reporting and execution of Recalls associated with any Collaboration Product, and the PMA Responsible Party will be the primary point of contact for any communications to the FDA and other Governmental Authorities, the media and customers concerning the Recall.
Each PMA Responsible Party will promptly inform the other Party regarding the receipt or denial of PMA Approval for any Collaboration Product for which it is responsible.
An LDT does not include an in vitro diagnostic product that has PMA Approval.
Each PMA Responsible Party will provide the other Party with a copy of all final Regulatory Submissions for which it is responsible, and related correspondence (e.g., requests for additional information from a relevant Regulatory Authority and responses thereto), communications or meeting minutes that involve a material discussion of a Collaboration Product promptly after submission to or receipt from the relevant Regulatory Authority.
Each PMA Responsible Party will keep the other Party reasonably informed with respect to the progress of obtaining PMA Approval of any Collaboration Product for which it is responsible.