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Filing a MAF for Balloon-Expandable Stent with the U.S. FDA


Filing a medical device master file (MAF) for Balloon-Expandable Stent can be a useful mechanism to market your Balloon-Expandable Stent to the U.S. Medical Device Industry. Typical Balloon-Expandable Stent producers who have filed a MAF for Balloon-Expandable Stent include:

  - CORDIS CORP.

Registrar Corp can help you to properly prepare and submit your Balloon-Expandable Stent MAF to FDA.

As your Agent, Registrar Corp will perform the following administrative functions:

  - Ensure administrative accuracy of your Balloon-Expandable Stent MAF
  - Format, assemble and deliver your Balloon-Expandable Stent MAF to FDA
  - Assist with preparing letters of authorization regarding your Balloon-Expandable Stent MAF
 - Provide changes, additions and maintenance of your Balloon-Expandable Stent MAF
  - Respond to issues relating to ownership of your Balloon-Expandable Stent MAF
  - Assist with submission of responses to FDA concerning your Balloon-Expandable Stent MAF

For more information about filing a MAF for Balloon-Expandable Stent, simply click below:




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U.S. FDA Regulations:

U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.


Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.
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