M 22

FDA Filings

This page includes the latest FDA filings for M 22. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3008937136
• FEI Number: 3008937136
• Name: Nathan Wildgrube
• Owner & Operator: M 22
• Contact Address: ZA - 230A route des Bouveries ; Saint-Nazaire-en-Royans FR-V Rhone-Alpes 26190 FR
• Official Correspondent:
  • Alban DENIS
  • 33-4-7548183-5
• US Agent:
  • Nathan Wildgrube
  • OSSUR AMERICAS
  • 949 4347018
  • nwildgrube@ossur.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 27051 Town Centre Drive ; Foothill Ranch, CA 92610 US
• Establishment Type: Manufacture Medical Device for Another Party (Contract Manufacturer)

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• MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT8200 Coral Sea Street N.e.mounds View, MN 55112 PMA NumberP010031 Supplement NumberS808 Date Received11/16/2022 Decision Date11/22/2022 Product Code NIK  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• MEDTRONIC Inc.8200 Coral Sea Street Nems Mv S11mounds View, MN 55112 PMA NumberP980035 Supplement NumberS734 Date Received11/16/2022 Decision Date11/22/2022 Product Code NVZ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
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• Medtronic, Inc.8200 Coral Sea Street N.e.mounds View, MN 55112 PMA NumberP930039 Supplement NumberS247 Date Received11/16/2022 Decision Date11/22/2022 Product Code NVN  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT8200 Coral Sea Street N.e.mounds View, MN 55112 PMA NumberP850089 Supplement NumberS163 Date Received11/16/2022 Decision Date11/22/2022 Product Code NVN  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
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• MEDTRONIC Inc.8200 Coral Sea Street Nems Mv S11mounds View, MN 55112 PMA NumberP980035 Supplement NumberS733 Date Received11/14/2022 Decision Date11/18/2022 Product Code NVZ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
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• Medtronic Inc.8200 Coral Sea Streetmounds View, MN 55112 PMA NumberP200028 Supplement NumberS014 Date Received10/17/2022 Decision Date11/16/2022 Product Code OAE  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No
• MEDTRONIC NEUROMODULATION7000 Central Avenue Nems Rcw225minneapolis, MN 55432 PMA NumberP080025 Supplement NumberS270 Date Received10/18/2022 Decision Date11/16/2022 Product Code QON  Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• MEDTRONIC NEUROMODULATION7000 Central Avenue Neminneapolis, MN 55432 PMA NumberP840001 Supplement NumberS531 Date Received10/18/2022 Decision Date11/16/2022 Product Code LGW  Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• MEDTRONIC NEUROMODULATION7000 Central Avenue, N.e.minneapolis, MN 55432 PMA NumberP970004 Supplement NumberS375 Date Received10/18/2022 Decision Date11/16/2022 Product Code EZW  Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Myriad Genetic Laboratories, Inc320 Wankara Waysalt Lake City, UT 84108 PMA NumberP190014 Supplement NumberS007 Date Received10/17/2022 Decision Date11/14/2022 Product Code PJG  Advisory Committee Pathology Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
• MEDTRONIC Inc.7000 Central Avenue Neminneapolis, MN 55432-3576 PMA NumberP860004 Supplement NumberS401 Date Received10/20/2022 Decision Date11/14/2022 Product Code LKK  Advisory Committee General Hospital Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• MEDTRONIC Inc.8200 Coral Sea Street Nems Mv S11mounds View, MN 55112 PMA NumberP150033 Supplement NumberS160 Date Received11/04/2022 Decision Date11/11/2022 Product Code PNJ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• MYRIAD GENETIC LABORATORIES320 Wakara Waysalt Lake City, UT 84108 PMA NumberP140020 Supplement NumberS024 Date Received10/14/2022 Decision Date11/10/2022 Product Code PJG  Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Medtronic CryoCath LP8200 Coral Sea Streetms Mvs46mounds View, MN 55112 PMA NumberP100010 Supplement NumberS132 Date Received10/28/2022 Decision Date11/09/2022 Product Code OAE  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• MEDTRONIC VASCULAR INC3033 Campus Driveplymouth, MN 55441 PMA NumberP140018 Supplement NumberS035 Date Received10/12/2022 Decision Date11/08/2022 Product Code PJQ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• MEDTRONIC Inc.8200 Coral Sea Street Nems Mv S11mounds View, MN 55112 PMA NumberP150033 Supplement NumberS155 Date Received10/03/2022 Decision Date11/04/2022 Product Code PNJ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Medtronic, Inc.710 Medtronic Parkwayminneapolis,, MN 55432 PMA NumberP130021 Supplement NumberS123 Date Received10/25/2022 Decision Date11/03/2022 Product Code NPT  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• MEDTRONIC Inc.8200 Coral Sea Street Nems Mv S11mounds View, MN 55112 PMA NumberP150033 Supplement NumberS156 Date Received10/24/2022 Decision Date11/03/2022 Product Code PNJ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Micro Therapeutics, Inc. D/b/a Ev3 NEUROVASCULAR9775 Toledo Wayirvine, CA 92618 PMA NumberP100018 Supplement NumberS037 Date Received08/09/2022 Decision Date11/02/2022 Product Code OUT  Advisory Committee Neurology Supplement Typereal-time Process Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• MEDTRONIC Inc.3576 Unocal Plsanta Rosa, CA 95403 PMA NumberP140010 Supplement NumberS070 Date Received10/31/2022 Decision Date11/01/2022 Product Code ONU  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Medtronic, Inc.3576 Unocal Placebuilding Asanta Rosa, CA 95403 PMA NumberP200046 Supplement NumberS012 Date Received10/31/2022 Decision Date11/01/2022 Product Code NPV  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Medtronic Vascular3576 Unocal Placesanta Rosa, CA 95403 PMA NumberP100040 Supplement NumberS053 Date Received10/31/2022 Decision Date11/01/2022 Product Code MIH  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• MEDTRONIC VASCULAR3576 Unocal Placesanta Rosa, CA 95403 PMA NumberP160043 Supplement NumberS062 Date Received10/31/2022 Decision Date11/01/2022 Product Code NIQ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Medtronic Vascular Inc.3576 Unocal Placesanta Rosa, CA 95403 PMA NumberP190008 Supplement NumberS021 Date Received10/31/2022 Decision Date11/01/2022 Product Code PRC  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Medtronic, Inc.710 Medtronic Parkwayminneapolis,, MN 55432 PMA NumberP130021 Supplement NumberS125 Date Received10/28/2022 Decision Date11/01/2022 Product Code NPT  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• MEDTRONIC Inc.8200 Coral Sea Street Nems Mv S11mounds View, MN 55112 PMA NumberP150033 Supplement NumberS157 Date Received10/31/2022 Decision Date11/01/2022 Product Code PNJ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Medtronic Vascular3576 Unocal Placesanta Rosa, CA 95403 PMA NumberP100021 Supplement NumberS108 Date Received10/31/2022 Decision Date11/01/2022 Product Code MIH  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Moisture 22 Co., Ltd
• MSN Laboratories Private Limited 317, 320, 321, 322, 323, 604 & 605, Rudraram, Patancheru (Mandal), Sangareddy District, Telangana 502329, India