Dermagraft to resubmit US PMA (pre-market approval) within two months:
This article was originally published in Clinica
Executive Summary
Advanced Tissue Sciences has completed the enrolment of subjects for its trial of the human tissue-based Dermagraft skin graft in treating diabetic foot ulcers. The La Jolla, California-based company expects to submit a PMA to the US FDA before the end of September. The company's first PMA, in 1998, was rejected by the agency.