PMI's Special 510(k) gets FDA nod
This article was originally published in Clinica
The US FDA has cleared the Special 510(k) application submistted by Power Medical Interventions (PMI) for its i45V Intelligent Surgical Instrument and 45mm reload cartridge. The submission was made on July 22 (see Clinica No 1316, p 18). The Langhorne, Pennsylvania company intends to launch the product in early August.