analitycs external username:
Your document can be opened using the below link
Download Full Article
Thank you, please click link below to continue
We have more than 30 years of experience creating silicone solutions of the utmost purity for long-term medical implants, including lifesaving and life-changing devices such as pacemakers.
From our early days of developing materials for intraocular lenses (IOL) and aesthetic implants, the NuSil™ brand has remained the market leader and a steady supplier of implantable silicones. Over decades, we've continued to introduce new and custom solutions for medical devices with our Implant line serving applications such as pacemakers, cochlear implants, hydrocephalus shunts and implantable infusion pumps.
This spirit of innovation, and our continued commitment to the medical device market through our award-winning customer care and regulatory support, has made us the premiere choice of the world's leading healthcare companies. These industry leaders trust the quality, purity and reliability of our medical-grade products to succeed in a heavily regulated market where failure is not an option.
For over 35 years, the NuSil™ brand has been assisting medical device and pharmaceutical companies in obtaining regulatory clearance for their products. That commitment extends well beyond the sale of our silicones. We provide the technical and regulatory expertise needed for approval and are willing to communicate directly with regulatory authorities on behalf of our customers.
We have submitted over 700 Master Access Files (MAFs) to the United States Food & Drug Administration (FDA) and international authorities in support of our medical grade silicones. A critical element of our MAFs is the biological testing conducted by NuSil™ on the products found in this guide. Our Implant Line of materials meet the test requirements listed in our Product Guide.
Discover how Medical-grade silicones are specifically designed, manufactured and purified to meet the strictest needs of the healthcare industry.
Our signature Medical Implant line offers a complete range of silicones designed specifically for long-term implant in the body. They are considered “unrestricted,” meaning they can be in the body for any length of time. This line comes fully supported with Master Access Files.
Click here to view the Medical Implant product guide.