A V Ent

FDA Filings

This page includes the latest FDA filings for A V Ent. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Owner/Operator Registration

FDA Filings

Device Company	Device	Date
PMN K921713 A AND V ENT.	DENTAL ROOT CANAL BACTERIALCIDAL LUBRICANT	1993-11-04

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• ABBOTT VASCULAR3200 Lakeside Drivesanta Clara, CA 95054 PMA NumberP040012 Supplement NumberS064 Date Received11/21/2022 Decision Date01/31/2023 Product Code NIM  Advisory Committee Cardiovascular Supplement Type135 Review Track For 30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
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• Abbott Medical177 County Road B. Eastst. Paul, MN 55117 PMA NumberP100029 Supplement NumberS049 Date Received11/18/2022 Decision Date12/14/2022 Product Code LWR  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
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• Abbott Laboratories100 Abbott Park Roaddept: 09aa Bldg: Ap8-1abbott Park, IL 60064 PMA NumberP210003 Supplement NumberS003 Date Received11/07/2022 Decision Date12/07/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Abbott Laboratories100 Abbott Park Rd.dept 09v6, Bldg. Ap5-2abbott Park, IL 60064-6088 PMA NumberP110029 Supplement NumberS040 Date Received11/07/2022 Decision Date12/07/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
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• Abbott Medical15900 Valley View Courtsylmar, CA 91335 PMA NumberP140033 Supplement NumberS076 Date Received09/08/2022 Decision Date12/07/2022 Product Codes LWP NVN  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• Abbott Medical177 County Road B. Eastst. Paul, MN 55117 PMA NumberP100029 Supplement NumberS048 Date Received10/20/2022 Decision Date12/06/2022 Product Code LWR  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Abiomed, Inc.22 Cherry Hill Drivedanvers, MA 01923 PMA NumberP170011 Supplement NumberS047 Date Received11/03/2022 Decision Date12/05/2022 Product Code PYX  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
• AcuFocus, Inc.32 Discoverysuite 200irvine, CA 92618 PMA NumberP210005 Supplement NumberS004 Date Received11/04/2022 Decision Date12/02/2022 Product Code POE  Advisory Committee Ophthalmic Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No
• Abbott Molecular, Inc.1300 East Touhy Avenuedes Plaines, IL 60018 PMA NumberP170041 Supplement NumberS006 Date Received12/17/2021 Decision Date12/01/2022 Product Code OWD  Advisory Committee Clinical TrialsNCT02719574 Supplement Typenormal 180 Day Track Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
• ARJ Medical Inc.209 State Street Eoldsmar, FL 34677 PMA NumberP170022 Supplement NumberS001 Date Received05/04/2022 Decision Date11/30/2022 Product Code OZA  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• Abbott Medical177 County Road B. Eastst. Paul, MN 55117 PMA NumberP100029 Supplement NumberS047 Date Received10/20/2022 Decision Date11/29/2022 Product Code LWR  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Abbott Molecular, Inc.1300 E. Touhy Avenuedes Plaines, IL 60018 PMA NumberP210022 Supplement NumberS002 Date Received11/03/2022 Decision Date11/28/2022 Product Code PAB  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• ABBOTT VASCULAR (IDEF TECHNOLOGIES INC)3200 Lakeside Drivesanta Clara, CA 95054 PMA NumberP120020 Supplement NumberS028 Date Received09/30/2022 Decision Date11/22/2022 Product Code NIP  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• Abbott Medical177 Country Road B Eastst. Paul, MN 55117 PMA NumberP100009 Supplement NumberS049 Date Received11/09/2022 Decision Date11/20/2022 Product Code NKM  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• ATRICURE INC.7555 Innovation Waymason, OH 45040 PMA NumberP100046 Supplement NumberS013 Date Received03/01/2022 Decision Date11/15/2022 Product Code OCM  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• Abbott Medical6035 Stoneridge Drivepleasanton, CA 94588 PMA NumberP060040 Supplement NumberS088 Date Received10/25/2022 Decision Date11/10/2022 Product Code DSQ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Abbott Medical177 County Road B. Eastst. Paul, MN 55117 PMA NumberP190023 Supplement NumberS010 Date Received08/12/2022 Decision Date11/09/2022 Product Code NPT  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• Anika Therapeutics, Inc.32 Wiggins Avenuebedford, MA 01730 PMA NumberP030019 Supplement NumberS027 Date Received10/12/2022 Decision Date11/08/2022 Product Code MOZ  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Anika Therapeutics, Inc.32 Wiggins Avenuebedford, MA 01730 PMA NumberP090031 Supplement NumberS015 Date Received10/12/2022 Decision Date11/08/2022 Product Code MOZ  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Anika Therapeutics, Inc.32 Wiggins Avenuebedford, MA 01730 PMA NumberP090031 Supplement NumberS014 Date Received10/03/2022 Decision Date11/04/2022 Product Code MOZ  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
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• Axonics Modulation Technologies, Inc.26 Technology Driveirvine, CA 92618 PMA NumberP190006 Supplement NumberS061 Date Received09/19/2022 Decision Date11/01/2022 Product Code QON  Advisory Committee Gastroenterology/Urology Supplement Typenormal 180 Day Track Supplement Reason Location Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Axonics Modulation Technologies, Inc.26 Technology Driveirvine, CA 92618 PMA NumberP180046 Supplement NumberS061 Date Received09/19/2022 Decision Date11/01/2022 Product Code EZW  Advisory Committee Gastroenterology/Urology Supplement Typenormal 180 Day Track Supplement Reason Location Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
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• Abbott Medical6901 Preston Roadplano, TX 75024 PMA NumberP010032 Supplement NumberS194 Date Received09/29/2022 Decision Date10/28/2022 Product Code LGW  Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Axonics Modulation Technologies, Inc.26 Technology Driveirvine, CA 92618 PMA NumberP170023 Supplement NumberS013 Date Received09/27/2022 Decision Date10/26/2022 Product Code LNM  Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Axonics Modulation Technologies, Inc.26 Technology Driveirvine, CA 92618 PMA NumberP170023 Supplement NumberS012 Date Received09/27/2022 Decision Date10/26/2022 Product Code LNM  Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Abbott Laboratories100 Abbott Park Rd.ap5n-2, Dept. 09vbabbott Park, IL 60064-3500 PMA NumberP060035 Supplement NumberS036 Date Received09/27/2022 Decision Date10/25/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Abbott Laboratories100 Abbott Park Rd.ap5n-2, Dept. 09vbabbott Park, IL 60064 PMA NumberP080023 Supplement NumberS038 Date Received09/27/2022 Decision Date10/25/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Abbott Molecular, Inc.1300 E Touhy Avedes Plaines, IL 60018 PMA NumberP200013 Supplement NumberS009 Date Received09/21/2022 Decision Date10/24/2022 Product Code MKT  Advisory Committee Microbiology Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
• Abbott Medical6901 Prestion Roadplano, TX 75024 PMA NumberP140009 Supplement NumberS079 Date Received09/21/2022 Decision Date10/17/2022 Product Code MHY  Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Abbott Medical177 Country Road B Eastst. Paul, MN 55117 PMA NumberP100009 Supplement NumberS048 Date Received10/11/2022 Decision Date10/17/2022 Product Code NKM  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Abbott Medical6035 Stoneridge Drivepleasanton, CA 94588 PMA NumberP060040 Supplement NumberS087 Date Received09/15/2022 Decision Date10/14/2022 Product Code DSQ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Abbott Medical6035 Stoneridge Drivepleasanton, CA 94588 PMA NumberP160054 Supplement NumberS049 Date Received09/15/2022 Decision Date10/14/2022 Product Code DSQ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• AtriCure, Inc.7555 Innovation Waywest Chester, OH 45040 PMA NumberP200002 Supplement NumberS003 Date Received09/13/2022 Decision Date10/13/2022 Product Code OCM  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No
• Abbott Laboratories100 Abbott Park Rd.dept 09v6, Bldg. Ap5-2abbott Park, IL 60064-6088 PMA NumberP110029 Supplement NumberS039 Date Received09/14/2022 Decision Date10/12/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• ABBOTT LABORATORIES INC100 Abbott Park Roaddept 9va- Ap8-1abbott Park, IL 60064 PMA NumberP050051 Supplement NumberS047 Date Received09/14/2022 Decision Date10/12/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Abbott Laboratories100 Abbott Park Rd.abbott Park, IL 60064-3500 PMA NumberP910007 Supplement NumberS058 Date Received09/14/2022 Decision Date10/12/2022 Product Code MTF  Advisory Committee Immunology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Abbott Laboratories100 Abbott Park Rd.ap5n-2 Dept 09vbabbott Park, IL 60064-6070 PMA NumberP980007 Supplement NumberS047 Date Received09/14/2022 Decision Date10/12/2022 Product Code MTG  Advisory Committee Immunology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Abbott Laboratories100 Abbott Park Rd.ap5n-2, Dept. 09vbabbott Park, IL 60064 PMA NumberP080023 Supplement NumberS037 Date Received09/14/2022 Decision Date10/12/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Abbott Laboratories100 Abbott Park Rd.ap5n-2, Dept. 09vbabbott Park, IL 60064-3500 PMA NumberP060035 Supplement NumberS035 Date Received09/14/2022 Decision Date10/12/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Abbott Laboratories100 Abbott Park Roaddept: 09aa Bldg: Ap8-1abbott Park, IL 60064 PMA NumberP210003 Supplement NumberS002 Date Received09/14/2022 Decision Date10/12/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Abbott Laboratories09v6 Ap5-2n100 Abbott Park Roadabbott Park, IL 60064 PMA NumberP120008 Supplement NumberS020 Date Received09/14/2022 Decision Date10/12/2022 Product Code LOK  Advisory Committee Immunology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Abiomed, Inc.22 Cherry Hill Drivedanvers, MA 01923 PMA NumberP170011 Supplement NumberS046 Date Received09/15/2022 Decision Date10/11/2022 Product Code PYX  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Abbott Medical15900 Valley View Courtsylmar, CA 91342 PMA NumberP150035 Supplement NumberS002 Date Received09/21/2022 Decision Date10/06/2022 Product Code PNJ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Allergan2525 Dupont Dr.irvine, CA 92612 PMA NumberP020056 Supplement NumberS058 Date Received04/01/2022 Decision Date10/05/2022 Product Code FTR  Advisory Committee General & Plastic Surgery Supplement Type135 Review Track For 30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Allergan2525 Dupont Dr.irvine, CA 92612 PMA NumberP990074 Supplement NumberS049 Date Received04/01/2022 Decision Date10/05/2022 Product Code FWM  Advisory Committee General & Plastic Surgery Supplement Type135 Review Track For 30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• APOLLO ENDOSURGERY INC1120 S Capital Of Tx Hwybldg 1, Ste 300austin, TX 78746-0000 PMA NumberP140008 Supplement NumberS024 Date Received07/11/2022 Decision Date10/05/2022 Product Code LTI  Advisory Committee Gastroenterology/Urology Supplement Typereal-time Process Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
• Altacor Ltd.merlin House, Brunel Roadtheale RG7 4 PMA NumberP960011 Supplement NumberS034 Date Received09/08/2022 Decision Date10/03/2022 Product Code LZP  Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Abbott Laboratories100 Abbott Park Roaddept: 09aa Bldg: Ap8-1abbott Park, IL 60064 PMA NumberP210003 Supplement NumberS001 Date Received09/09/2022 Decision Date09/30/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Abbott Laboratories100 Abbott Park Rd.dept 09v6, Bldg. Ap5-2abbott Park, IL 60064-6088 PMA NumberP110029 Supplement NumberS038 Date Received09/09/2022 Decision Date09/30/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Abbott Medical15900 Valley View Courtsylmar, CA 91335 PMA NumberP030035 Supplement NumberS191 Date Received07/27/2022 Decision Date09/30/2022 Product Code NKE  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• Abbott Medical15900 Valley View Courtsylmar, CA 91335 PMA NumberP140033 Supplement NumberS075 Date Received07/27/2022 Decision Date09/30/2022 Product Codes LWP NVN  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• Abbott Medical15900 Valley View Courtsylmar, CA 91335 PMA NumberP970013 Supplement NumberS091 Date Received07/27/2022 Decision Date09/30/2022 Product Code LWO  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• ABBOTT LABORATORIES INC100 Abbott Park Roaddept 9va- Ap8-1abbott Park, IL 60064 PMA NumberP050051 Supplement NumberS046 Date Received09/09/2022 Decision Date09/30/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Abbott Medical15900 Valley View Courtsylmar, CA 91335 PMA NumberP880086 Supplement NumberS325 Date Received07/27/2022 Decision Date09/30/2022 Product Code DXY  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• ALCON LABORATORIES6201 South Freewayfort Worth, TX 76134 PMA NumberP990023 Supplement NumberS018 Date Received08/24/2022 Decision Date09/22/2022 Product Code LZP  Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• ANGEL MEDICAL SYSTEMS INC.788 Shrewsbury Ave Suite 2200tinton Falls, NJ 07724 PMA NumberP150009 Supplement NumberS008 Date Received08/19/2022 Decision Date09/21/2022 Product Code QBI  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
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