Medical Device

Sientra, (NASDAQ:SIEN) a medical aesthetics company, today provided an update on its pre-market approval (PMA) supplement for a site-change to its U.S. manufacturing facility. Following a successful inspection and resolution of minor 483 observations, the U.S. Food and Drug Administration (FDA) has granted approval of the site-change PMA supplement for its contract manufacturer (Vesta) to …

Sientra, (NASDAQ:SIEN) a medical aesthetics company, today provided an update on its pre-market approval (PMA) supplement for a site-change to its U.S. manufacturing facility. Following a successful inspection and resolution of minor 483 observations, the U.S. Food and Drug Administration (FDA) has granted approval of the site-change PMA supplement for its contract manufacturer (Vesta) to manufacture Sientra’s silicone gel breast implants.
As quoted in the press release:

Jeffrey M. Nugent, Chairman and Chief Executive Officer of Sientra, commented, “We have maintained our belief that FDA approval to manufacture our best in class breast implants at Vesta’s U.S. facility was a “when” and not an “if” situation.  Today, we are very pleased to announce that we have made significant progress with the FDA towards that goal.  Notably, the approval of the site-change PMA supplement was a critical step as it approves the Vesta manufacturing site.”

Click here to read the full press release.

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