T
Hello!
I am studying a subject title "Regulatory Requirements". I have a simple question which has confused me alot. I will be thankful if anyone could clarify me on this.
A pacemaker's lead (/electrode cable) "insulation material" has changed from silicone to the novel polyurethane . In this case we have to file for 510K. I read this article on FDA website attached as PDF with this post.
The question is that whether we will have to file a new PMA 510k application or a special 510K submission would work.
I will be thankful if you could refer me to some flowchart or document which explains this.
I am studying a subject title "Regulatory Requirements". I have a simple question which has confused me alot. I will be thankful if anyone could clarify me on this.
A pacemaker's lead (/electrode cable) "insulation material" has changed from silicone to the novel polyurethane . In this case we have to file for 510K. I read this article on FDA website attached as PDF with this post.
The question is that whether we will have to file a new PMA 510k application or a special 510K submission would work.
I will be thankful if you could refer me to some flowchart or document which explains this.
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