The FDA warned Allergan last month about marketing the Seri surgical scaffold in the U.S. for breast surgery indications without marketing clearance or approval.
An FDA review of Allergan’s Seri website reported the scaffold was being marketted for breast surgery applications, which the federal watchdog says “would constitute a major change or modification to its intended use, for which your firm lacks clearance or approval.”
The Seri Scaffold had indications for “use as a transitory scaffold for soft tissue support and repair to reinforce deficiencies where weakness or voids exist that require the addition of material to obtain the desired surgical outcome,” according to the letter.
Help employers find you! Check out all the jobs and post your resume.
An FDA review of Allergan’s Seri website reported the scaffold was being marketted for breast surgery applications, which the federal watchdog says “would constitute a major change or modification to its intended use, for which your firm lacks clearance or approval.”
The Seri Scaffold had indications for “use as a transitory scaffold for soft tissue support and repair to reinforce deficiencies where weakness or voids exist that require the addition of material to obtain the desired surgical outcome,” according to the letter.
Help employers find you! Check out all the jobs and post your resume.
