Thanks glyco As per the fda guidelines it takes up to 45 days for filing and 180 days for review, without amendments or requests it seems. So probably not long! If any ones interested re PMA review process compared to 510(k) https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketApprovalPMA/ucm047991.htm
Top 20 List GMV, page-74
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