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On Mon, Jan 11, 2010 at 9:17 AM, Dan Goldstein
<DGoldstein -at- riverainmedical -dot- com> wrote:
> If J&J's initial requirement had been something
> like, "the product shall have a 40-page manual," the PMA review for the
> stent would have lit up a few red lights at the agency.
J&J mustn't have much for a quality check before releasing the
labeling, though -- and that might show up if there's ever an audit.
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