ok heres what i found out.from the guy i know at work whom knows some hot shot in the fda.
prodisc failed mfg code 5 10k inspection for tier1 rated device. will be re inspected in 30 to 90 days
once they pass this inspection,offical approval will come in 2 weeks following.
seems this tier1 rating is a prefered insurance rating i suppose meaning more insurance company will pick up the device as standard.
chuck
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