Advanced Neuromodulation Systems criticises FDA's "protection" of Medtronic
This article was originally published in Clinica
Executive Summary
Advanced Neuromodulation Systems (ANS) has slammed the US FDA's "stunning decision" not to reclassify ANS' totally implanted pulse generator (IPG) from a class III device to a class II. As a result, the company will take the lengthy PMA route, rather than file a 510(k), which could have seen the product on the market by the third quarter of this year (see Clinica No 947, p 16).