Podcast
Questions and Answers
What is unique about the training courses offered for PDO Max threads?
What is unique about the training courses offered for PDO Max threads?
- They offer online training modules rather than in-person experience, for better flexibility.
- They focus on training staff on regulatory requirements and FDA documentation.
- They involve a full day of hands-on experience with multiple patients and extensive thread usage. (correct)
- They are shorter than most company's courses, focusing only on the essential information.
Why is it important to verify the 510K documentation when selecting a PDO thread company?
Why is it important to verify the 510K documentation when selecting a PDO thread company?
- To confirm that the PDO threads, when inserted into a cannula, have a correct individual FDA clearance. (correct)
- To ensure the company is authorized to distribute in specific regions, adhering to import laws.
- To check if the company’s product line matches the ones offered across the market.
- To see if the company offers the best price compared to other companies selling the same PDO threads.
What is the typical recovery time after a PDO thread treatment?
What is the typical recovery time after a PDO thread treatment?
- A few weeks, where the patient must avoid social interactions due to swelling.
- A few months, requiring extensive aftercare and medication.
- A day, with minor inflammation and bruising that might take up to two weeks to resolve. (correct)
- Several days, with the patient needing to abstain from most physical activities.
How does the company ensure the quality and safety of its PDO threads and cannulas?
How does the company ensure the quality and safety of its PDO threads and cannulas?
What does it mean that PDO Max is the specification developer for its products?
What does it mean that PDO Max is the specification developer for its products?
What is a consequence of inserting a PDO thread into a cannula?
What is a consequence of inserting a PDO thread into a cannula?
How many patients does the in-house training workshop at PDO Max typically involve?
How many patients does the in-house training workshop at PDO Max typically involve?
What is the main objective of the intensive training program offered by the company?
What is the main objective of the intensive training program offered by the company?
Flashcards
What is a 510(k) Submission?
What is a 510(k) Submission?
A process where a company submits an application to the FDA to demonstrate that their medical device is safe and effective.
Why do PDO threads in a cannula need separate FDA clearance?
Why do PDO threads in a cannula need separate FDA clearance?
PDO threads combined with a cannula are considered a new medical device and require separate FDA clearance.
What are the benefits of using PDO threads made in South Korea?
What are the benefits of using PDO threads made in South Korea?
Manufacturers in the US are required to meet specific standards and have insurance to ensure safety and quality.
What does ISO 13485 Certification mean for PDO Max threads?
What does ISO 13485 Certification mean for PDO Max threads?
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What is PDO Thread Treatment?
What is PDO Thread Treatment?
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What is the typical recovery time for PDO thread treatment?
What is the typical recovery time for PDO thread treatment?
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What is PDO Max thread training like?
What is PDO Max thread training like?
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How does the company ensure the quality of its PDO threads?
How does the company ensure the quality of its PDO threads?
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Study Notes
PDO Max Threads: Key Information
- FDA Clearance: PDO threads, when inserted into a cannula, require a separate FDA clearance as a distinct device. Companies claiming FDA clearance for pre-loaded threads in cannulas may be misrepresenting their status. Always verify the 510K documentation.
- Training: Comprehensive, hands-on training courses are offered, including experience inserting hundreds of threads on multiple patients (4). These classes cover multiple treatment areas and use company-provided threads.
- Product Development: The company designs and manufactures its own PDO Max thread models, rather than importing existing products.
- Manufacturing: PDO Max threads and cannulas are manufactured in South Korea by a certified and insured manufacturer compliant with FDA clearance and ISO 13485 standards.
- Recovery Time: The minimally invasive nature of PDO thread treatments results in a quick recovery time. Most patients resume normal activities within a day.
- Potential Side Effects: Minor inflammation and bruising may be present for a few days, and usually resolve after two weeks.
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