The FDA has lifted the December 2005 warning letter on Guidant implantable cardioverter defibrillators (ICDs) that suspended Boston Scientific's introduction of new Guidant products. It took Boston Scientific a full year to retool their quality systems and backfill required documentation. The FDA reinspected the Guidant facilities last November and December, rending their decision almost 4 months later. From the Boston Globe story:
Scientific received from the FDA in January 2006. That letter applies
to its drug-coated stent business and the rest of the pre-Guidant areas
of the company. Executives have said they do not expect the warning
issue to be resolved until the second half of this year. Until then,
the company will be prevented from receiving agency approval of any new
models of drug-coated stents.
Congrats to Boston Scientific. Pictured right is the Guidant Contak Renewal ICD.