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|Lubrizol Customer, Sientra, Inc., Receives FDA Approval to Manufacture Breast Implants at Lubrizol LifeSciences' Facility|
Lubrizol Customer, Sientra, Inc., Receives FDA Approval to Manufacture Breast Implants at Lubrizol LifeSciences' Facility
CLEVELAND, February 6, 2018 -The Lubrizol Corporation announces that its customer, Sientra, Inc., a medical aesthetics company, has received U.S. Food and Drug Administration (FDA) approval of the site-change pre-market approval (PMA) supplement. This approval will enable Lubrizol LifeSciences to manufacture silicone gel breast implants for Sientra at its Franklin, Wisconsin facility.
Partnering with Sientra on this project leverages LifeSciences' recent investment to expand its global development and manufacturing facilities. Using Lubrizol's new 71,000-square foot facility which expands the company's silicone and thermoplastic capacity, Lubrizol LifeSciences is better positioned to serve Sientra and the growing medical device market.
"We are extremely pleased to work with Sientra on this project," states Uwe Winzen, general manager, Lubrizol LifeSciences. "With our new space offering enhanced product development capabilities, cellular manufacturing, and high-efficiency production lines in Class 7 & 8 clean rooms, we can accommodate the immediate needs for current product development with Sientra, and provide room for growth with Sientra, as well as other current and future customers."
For more information, please refer to Sientra Inc.'s press release.
About Lubrizol LifeSciences
About The Lubrizol Corporation
With headquarters in Wickliffe, Ohio, Lubrizol owns and operates manufacturing facilities in 17 countries, as well as sales and technical offices around the world. Founded in 1928, Lubrizol has approximately 8,300 employees worldwide. Revenues for 2016 were $6.5 billion. For more information, visit Lubrizol.com.