Cryolife Inc 1655 Roberts Blvd N W Kennesaw Ga 30144 Pma Numberp970029 Supplement Numbers040 Date Received08 04 2022 Decision Date09 01 2022 Product Code Mno Advisory Committee Cardiovascular Supplement Typespecial Immediate Track Supplement Reason Labeling Change Indications Instructions Shelf Life Tradename Expedited Review Granted No

FDA Filings

This page includes the latest FDA filings for Cryolife Inc 1655 Roberts Blvd N W Kennesaw Ga 30144 Pma Numberp970029 Supplement Numbers040 Date Received08 04 2022 Decision Date09 01 2022 Product Code Mno Advisory Committee Cardiovascular Supplement Typespecial Immediate Track Supplement Reason Labeling Change Indications Instructions Shelf Life Tradename Expedited Review Granted No. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

FDA Filings

Device
Company
DeviceDate
CRYOLIFE, INC.1655 Roberts Blvd., N.w.kennesaw, GA 30144 PMA NumberP970029 Supplement NumberS040 Date Received08/04/2022 Decision Date09/01/2022 Product Code MNO  Advisory Committee Cardiovascular Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
CardioGenesis TMR System2022-09-01

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