Hold the Presses is your online newsportal en brings press releases from around the world. Journalists can use it for free, although it is their responsibilty to check the news. Hold the Presses is in no way responsible for the content of the press releases, the Sender is. We hope you enjoy reading the news we bring you on this website. If a message is published that is not acceptable, we apologize. Please contact us and we will remove the message as soon as possible.

Tuesday, 6 February 2018

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

 

 

 

News Release

 

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

Lubrizol LifeSciences is a preferred Contract Development and Manufacturing Organization (CDMO) partner for complex pharmaceuticals and high-end medical devices providing differentiated polymers and excipients, along with state-of-the-art design, development and manufacturing services to the healthcare industry.

 

About The Lubrizol Corporation

The Lubrizol Corporation, a Berkshire Hathaway company, is a market-driven global company that combines complex, specialty chemicals to optimize the quality, performance and value of customers' products while reducing their environmental impact. It is a leader at combining market insights with chemistry and application capabilities to deliver valuable solutions to customers in the global transportation, industrial and consumer markets. Lubrizol improves lives by acting as an essential partner in our customers' success, delivering efficiency, reliability or wellness to their end users. Technologies include lubricant additives for engine oils, driveline and other transportation-related fluids, industrial lubricants, as well as additives for gasoline and diesel fuel. In addition, Lubrizol makes ingredients and additives for home care, personal care and skin care products and specialty materials encompassing polymer and coatings technologies, along with polymer-based pharmaceutical and medical device solutions.

 

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.

 

Media Contact

Ben Patti

(216) 447-5827

www.lubrizol.com/LifeSciences

 

 

 

###






This announcement is distributed by Nasdaq Corporate Solutions (One Liberty Plaza, 165 Broadway, New York, NY 10006. Tel: +1 212 401 8700. www.nasdaqomx.com) on behalf of Nasdaq Corporate Solutions clients. Source: Lubrizol, 29400 Lakeland Boulevard, Wickliffe, Ohio 44092, USA
If you would like to unsubscribe and stop receiving these e-mails click here.