Lucideon Helps Greatbatch Medical to Gain FDA Acceptance

The Challenge

In an effort to supply its French-produced coated devices marketed by its customers into the US market, Greatbatch Medical needed to submit a detailed hydroxyapatite coating master file to FDA (Food and Drug Administration) in conjunction with the customer-submitted 510(k) submission.

Greatbatch Medical asked Lucideon (then known as Ceram) to provide the necessary testing on the coating for a hydroxyapatite coating master file submission.

What We Delivered

As part of its regulatory approval service, Lucideon developed a comprehensive testing programme to supply sound and complete data and analysis to support the submission.

Dr Richard White, Head of Testing at Lucideon, said:
"We are unique in that, thanks to our extensive analytical services, we can put together a complete testing regime for clients. Our aim is to take the guesswork out of what is needed to gain regulatory approval, by using our experience to put together all the chemical, physical and microstructural testing in a customized package. We then deliver credible data with full documentation and ongoing technical support."

Value to Greatbatch Medical

Thanks to the work that Lucideon did, Greatbatch Medical was able to fulfil FDA requirements for the submission of a hydroxyapatite coating master file with the result that the devices they are coating will now be able to be marketed by its customers in the US market.

Valéry Barbour, Quality Assurance - Customer Relation Manager, at Greatbatch Medical said:
"I would like to thank all of the Lucideon team that has worked on this file during the last few months for its great involvement in the project, strong expertise and excellent responsiveness.

"Working closely together allowed us to develop a comprehensive testing programme to fulfill FDA requirements for the submission of a hydroxyapatite coating master file.

"Lucideon's responsiveness to our questions really moved along the review of the file by FDA and we have really appreciated it! It was a challenging key milestone that we have successfully managed thanks to our new partnership."

Dr. Richard White said:
"We congratulate Greatbatch Medical on achieving FDA acceptance and believe that the whole process has highlighted the value of working so closely together."

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  • Regulatory Submission Support

    Pre- and post-regulatory approval testing