Enterra Ascent® has not been approved by the U.S. Food and Drug Administration (FDA). FDA has notified Enterra Medical that Enterra Ascent® and Enterra Entrust® may be distributed for implant under an FDA enforcement policy.
Enterra Ascent® has not been approved by the U.S. Food and Drug Administration (FDA). FDA has notified Enterra Medical that Enterra Ascent® and Enterra Entrust® may be distributed for implant under an FDA enforcement policy.