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Re: PJO post# 2368

Wednesday, 03/23/2016 12:39:04 PM

Wednesday, March 23, 2016 12:39:04 PM

Post# of 4218
The updated PMA will be filed when the required testing is done. The FDA wants more stats. The recent meeting with the new lead investigator was to develop the protocols the company would need to be able to submit the new PMA. We're a year away here in the U.S.
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