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Illumina, Inc.5200 Illumina Waysan Diego, CA 92122 PMA NumberP160038 Supplement NumberS024 Date Received12/22/2022 Decision Date01/13/2023 Product Code PQP Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
INTERSECT ENT1555 Adams Drmenlo Park, CA 94025 PMA NumberP100044 Supplement NumberS051 Date Received11/25/2022 Decision Date12/22/2022 Product Code OWO Advisory Committee Ear Nose & Throat Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
INTEGRA LIFESCIENCES CORPORATION311 Enterprise Dr.plainsboro, NJ 08536 PMA NumberP810006 Supplement NumberS101 Date Received11/21/2022 Decision Date12/19/2022 Product Code LMF Advisory Committee General & Plastic Surgery Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
INTEGRA LIFESCIENCES CORPORATION311 Enterprise Dr.plainsboro, NJ 08540 PMA NumberP850010 Supplement NumberS104 Date Received11/21/2022 Decision Date12/19/2022 Product Code LMF Advisory Committee General & Plastic Surgery Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
IRVINE BIOMEDICAL, INC.2375 Morse Ave.irvine, CA 92614 PMA NumberP040014 Supplement NumberS047 Date Received10/28/2022 Decision Date12/16/2022 Product Code LPB Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason Location Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
INSPIRE MEDICAL SYSTEMS9700 63rd Avenue Northsuite 200maple Grove, MN 55369 PMA NumberP130008 Supplement NumberS093 Date Received11/18/2022 Decision Date12/16/2022 Product Code MNQ Advisory Committee Anesthesiology Clinical TrialsNCT04457154 Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No
IRVINE BIOMEDICAL,INC.(IBI)2375 Morse Ave.irvine, CA 92614 PMA NumberP040042 Supplement NumberS054 Date Received11/14/2022 Decision Date12/08/2022 Product Code OAD Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Integra LifeSciences Corp.105 Morgan Ln.plainsboro, NJ 08536 PMA NumberP900033 Supplement NumberS103 Date Received11/14/2022 Decision Date12/07/2022 Product Code MGR Advisory Committee General & Plastic Surgery Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
IRVINE BIOMEDICAL,INC.(IBI)2375 Morse Ave.irvine, CA 92614 PMA NumberP040042 Supplement NumberS052 Date Received10/19/2022 Decision Date11/15/2022 Product Code OAD Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason Location Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
IRVINE BIOMEDICAL, INC.2375 Morse Ave.irvine, CA 92614 PMA NumberP040014 Supplement NumberS046 Date Received10/19/2022 Decision Date11/15/2022 Product Code LPB Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason Location Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
InSightec5 Nahum Heth Streettirat-hacarmet 39120 PMA NumberP150038 Supplement NumberS024 Date Received10/12/2022 Decision Date11/11/2022 Product Code POH Advisory Committee Neurology Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No
INTERSECT ENT1555 Adams Drmenlo Park, CA 94025 PMA NumberP100044 Supplement NumberS050 Date Received10/05/2022 Decision Date11/04/2022 Product Code OWO Advisory Committee Ear Nose & Throat Supplement Typespecial (immediate Track) Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
InSightec5 Nahum Heth Streettirat-hacarmet 39120 PMA NumberP150038 Supplement NumberS023 Date Received08/05/2022 Decision Date11/02/2022 Product Code POH Advisory Committee Neurology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
INTEGRA LIFESCIENCES CORPORATION311 Enterprise Dr.plainsboro, NJ 08536 PMA NumberP040034 Supplement NumberS035 Date Received09/07/2022 Decision Date10/07/2022 Product Code NQR Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
INTEGRA LIFESCIENCES CORPORATION311 Enterprise Dr.plainsboro, NJ 08536 PMA NumberP080013 Supplement NumberS024 Date Received09/07/2022 Decision Date10/07/2022 Product Code NQR Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
IBSA INSTITUT BIOCHIMIQUE SAvia Al Ponte 13, Ch-6903lugano Ticino 6903 PMA NumberP110005 Supplement NumberS012 Date Received09/08/2022 Decision Date10/07/2022 Product Code MOZ Advisory Committee Orthopedic Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
Intera Oncology65 William Streetsuite 200wellesley, MA 02481 PMA NumberP890055 Supplement NumberS083 Date Received08/30/2022 Decision Date09/29/2022 Product Code LKK Advisory Committee General Hospital Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Illumina, Inc.5200 Illumina Waysan Diego, CA 92122 PMA NumberP160038 Supplement NumberS023 Date Received08/18/2022 Decision Date08/30/2022 Product Code PQP Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
INSPIRE MEDICAL SYSTEMS9700 63rd Avenue Northsuite 200maple Grove, MN 55369 PMA NumberP130008 Supplement NumberS088 Date Received07/29/2022 Decision Date08/19/2022 Product Code MNQ Advisory Committee Anesthesiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Impulse Dynamics (USA), Inc.30 Ramland Road South, Suite 204orangeburg, NY 10962 PMA NumberP180036 Supplement NumberS015 Date Received07/22/2022 Decision Date08/18/2022 Product Code QFV Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No
INTEGRA LIFESCIENCES CORPORATION311 Enterprise Dr.plainsboro, NJ 08536 PMA NumberP810006 Supplement NumberS100 Date Received06/06/2022 Decision Date07/06/2022 Product Code LMF Advisory Committee General & Plastic Surgery Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
INTEGRA LIFESCIENCES CORP.311 Enterprise Dr.plainsboro, NJ 08536 PMA NumberP840062 Supplement NumberS086 Date Received06/06/2022 Decision Date07/06/2022 Product Code LPG Advisory Committee Dental Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
INTEGRA LIFESCIENCES CORPORATION311 Enterprise Dr.plainsboro, NJ 08540 PMA NumberP850010 Supplement NumberS103 Date Received06/06/2022 Decision Date07/06/2022 Product Code LMF Advisory Committee General & Plastic Surgery Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Illumina, Inc.5200 Illumina Waysan Diego, CA 92122 PMA NumberP160038 Supplement NumberS022 Date Received06/13/2022 Decision Date07/05/2022 Product Code PQP Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Integra LifeSciences Corp.105 Morgan Ln.plainsboro, NJ 08536 PMA NumberP900033 Supplement NumberS102 Date Received06/07/2022 Decision Date07/01/2022 Product Code MGR Advisory Committee General & Plastic Surgery Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
INTERSECT ENT1555 Adams Drmenlo Park, CA 94025 PMA NumberP100044 Supplement NumberS049 Date Received03/28/2022 Decision Date06/24/2022 Product Code OWO Advisory Committee Ear Nose & Throat Supplement Typereal-time Process Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Intera Oncology65 William Streetsuite 200wellesley, MA 02481 PMA NumberP890055 Supplement NumberS081 Date Received05/27/2022 Decision Date06/22/2022 Product Code LKK Advisory Committee General Hospital Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
INSPIRE MEDICAL SYSTEMS9700 63rd Avenue Northsuite 200maple Grove, MN 55369 PMA NumberP130008 Supplement NumberS084 Date Received05/20/2022 Decision Date06/16/2022 Product Code MNQ Advisory Committee Anesthesiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
InSightec5 Nahum Heth Streettirat-hacarmet 39120 PMA NumberP150038 Supplement NumberS021 Date Received03/10/2022 Decision Date06/07/2022 Product Code POH Advisory Committee Neurology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
Integra LifeSciences Corp.105 Morgan Ln.plainsboro, NJ 08536 PMA NumberP900033 Supplement NumberS100 Date Received04/20/2022 Decision Date05/20/2022 Product Code MGR Advisory Committee General & Plastic Surgery Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
INTEGRA LIFESCIENCES CORPORATION311 Enterprise Dr.plainsboro, NJ 08536 PMA NumberP810006 Supplement NumberS099 Date Received04/20/2022 Decision Date05/20/2022 Product Code LMF Advisory Committee General & Plastic Surgery Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
INTEGRA LIFESCIENCES CORP.311 Enterprise Dr.plainsboro, NJ 08536 PMA NumberP840062 Supplement NumberS085 Date Received04/20/2022 Decision Date05/20/2022 Product Code LPG Advisory Committee Dental Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Intera Oncology65 William Streetsuite 200wellesley, MA 02481 PMA NumberP890055 Supplement NumberS080 Date Received04/26/2022 Decision Date05/20/2022 Product Code LKK Advisory Committee General Hospital Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
INTEGRA LIFESCIENCES CORPORATION311 Enterprise Dr.plainsboro, NJ 08540 PMA NumberP850010 Supplement NumberS102 Date Received04/20/2022 Decision Date05/20/2022 Product Code LMF Advisory Committee General & Plastic Surgery Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Integra LifeSciences Corp.105 Morgan Ln.plainsboro, NJ 08536 PMA NumberP900033 Supplement NumberS099 Date Received04/04/2022 Decision Date05/05/2022 Product Code MGR Advisory Committee General & Plastic Surgery Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
INTEGRA LIFESCIENCES CORP.311 Enterprise Dr.plainsboro, NJ 08536 PMA NumberP840062 Supplement NumberS084 Date Received04/04/2022 Decision Date04/28/2022 Product Code LPG Advisory Committee Dental Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
INTEGRA LIFESCIENCES CORPORATION311 Enterprise Dr.plainsboro, NJ 08536 PMA NumberP810006 Supplement NumberS098 Date Received04/04/2022 Decision Date04/28/2022 Product Code LMF Advisory Committee General & Plastic Surgery Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
INTEGRA LIFESCIENCES CORPORATION311 Enterprise Dr.plainsboro, NJ 08540 PMA NumberP850010 Supplement NumberS101 Date Received04/04/2022 Decision Date04/28/2022 Product Code LMF Advisory Committee General & Plastic Surgery Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
INTEGRA LIFESCIENCES CORPORATION311 Enterprise Dr.plainsboro, NJ 08540 PMA NumberP850010 Supplement NumberS100 Date Received03/21/2022 Decision Date04/20/2022 Product Code LMF Advisory Committee General & Plastic Surgery Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
INVIVOSCRIBE TECHNOLOGIES, INC10222 Barnes Canyon Road, Building 1san Diego, CA 92121 PMA NumberP160040 Supplement NumberS010 Date Received03/15/2022 Decision Date04/11/2022 Product Code OWD Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
INSPIRE MEDICAL SYSTEMS9700 63rd Avenue Northsuite 200maple Grove, MN 55369 PMA NumberP130008 Supplement NumberS083 Date Received03/15/2022 Decision Date04/07/2022 Product Code MNQ Advisory Committee Anesthesiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
INSPIRE MEDICAL SYSTEMS9700 63rd Avenue Northsuite 200maple Grove, MN 55369 PMA NumberP130008 Supplement NumberS082 Date Received03/02/2022 Decision Date04/01/2022 Product Code MNQ Advisory Committee Anesthesiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
InSightec5 Nahum Heth Streettirat-hacarmet 39120 PMA NumberP150038 Supplement NumberS020 Date Received03/08/2022 Decision Date03/31/2022 Product Code POH Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Illumina, Inc.5200 Illumina Waysan Diego, CA 92122 PMA NumberP160038 Supplement NumberS021 Date Received02/28/2022 Decision Date03/28/2022 Product Code PQP Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
IBSA INSTITUT BIOCHIMIQUE SAvia Al Ponte 13, Ch-6903lugano Ticino 6903 PMA NumberP110005 Supplement NumberS011 Date Received02/16/2022 Decision Date03/18/2022 Product Code MOZ Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
INSPIRE MEDICAL SYSTEMS9700 63rd Avenue Northsuite 200maple Grove, MN 55369 PMA NumberP130008 Supplement NumberS080 Date Received02/17/2022 Decision Date03/16/2022 Product Code MNQ Advisory Committee Anesthesiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
INSPIRE MEDICAL SYSTEMS9700 63rd Avenue Northsuite 200maple Grove, MN 55369 PMA NumberP130008 Supplement NumberS081 Date Received02/17/2022 Decision Date03/14/2022 Product Code MNQ Advisory Committee Anesthesiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
INSPIRE MEDICAL SYSTEMS9700 63rd Avenue Northsuite 200maple Grove, MN 55369 PMA NumberP130008 Supplement NumberS079 Date Received02/11/2022 Decision Date03/10/2022 Product Code MNQ Advisory Committee Anesthesiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
INSPIRE MEDICAL SYSTEMS
Impulse Dynamics (USA), Inc.
INVIVOSCRIBE TECHNOLOGIES, INC
INVERNESS MEDICAL PROFESSIONAL DIAGNOSTICS-BINAX
I Shay Cosmetics Inc
I. Shay Cosmetics
I.D.M. Medical Supply Company Inc.
I2 Strategic Solutions
I2 Strategic Solutions LLC
i3 Pharmaceuticals, LLC
i3 Pharmceuticals, LLC
IAM Acquisitions, LLC d/b/a Coregistics
Iam Center For Integrative Aesthetic Medicine LLC
Iatric Manufacturing Solutions LLC
Ibex Chemicals
ICF SRL
ICM Distributing Company, INC
Icon Health Science
Icon Health Science, LLC
Icon Health Services, Llc
ICS/AmerisourceBergen Specialty Group
IDEAL BEAUTY ALLIANCE SDN. BHD.
Ideal Chemical & Supply Co.
Iden Cosmetics, Inc.
Identi Pharmaceuticals LLC
Idorsia Pharmaceuticals Ltd
IFFCO KISISEL BAKIM URUNLERI SANAYI VE TICARET AS
Ignacio Reyes González
Ignacio Reyes Gonzalez
IIMED MEDICAL MEXICANA S DE RL DE CV
IIMED MEDICAL MEXICANA S. DE R.L. DE C.V
IJ Therapeutics, LLC
ILEX Consumer Products Group, LLC (ST. JOSEPH)
ILLINOIS HEMP PROCESSOR
ILMO Products
ILMO Products Company
I-TEK MEDICAL SOLUTIONS, INC.
I.A.E. INDUSTRIA APPLICAZIONI ELETTRONICHE SPA
I.M.S. INTERNAZIONALE MEDICO SCIENTIFICA SRL
IAA SURGICAL INSTRUMENTS COMPANY
Ibramed Industria Brasileira de Equipamentos Medicos Eir
IBSA FARMACEUTICI ITALIA SRL
ICAT SOLUTIONS LTD
Iconacy Orthopedic Implants LLC
ICU MEDICAL FLEET SERVICES, LLC
ILINE MICROSYSTEMS SL
Illés Csók és Társa Vegyeskereskedő Korlátolt Felelősségű Társaság
Imaging Sciences International
IMMUNODIAGNOSTIC SYSTEMS FRANCE
Immunodiagnostic Systems SA
IMMUNOSTICS COMPANY, INC
Implantable Devices
Implants and Attachments, Inc.
IMPULSE MEDICAL TECHNOLOGIES, INC.
INCELER MEDIKAL SAGLIK HIZMETLERI SANAYI TICARET LIMITED SIRKETI
Incipio Devices SA
INCISIVE SURGICAL, INC.
INCISIVE, LLC
Indenco Dental Products Inc
INDIUS MEDICAL TECHNOLOGIES PRIVATE LIMITED
INFINITE BIOMEDICAL TECHNOLOGIES, LLC
INFUSION SAFETY PRODUCTS, INC.
INGENIOUS TECHNOLOGIES CORPORATION
Inland Products, Inc.
Inmedico A/S
INNERSPACE NEURO SOLUTIONS, INC.
InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd)
Innova Medical Ophthalmics Inc
Innovative Medical Products, Inc
INNOVATIVE NEUROTRONICS, INC.
Innovative Ophthalmic Products, Inc
INNOVATIVE SURGICAL DESIGNS
INNOVATIVE SURGICAL SOLUTIONS LLC
Inspecs U.S.A., L.C.
Inspiration G5 LLC dba PlatypusCo
Instant Tech Subsidiary Acquisition
Instant Technologies, Inc.
Instarisa Technologies, LLC
INSTITUTO DE INVESTIGACION EN ORTOPEDIA AVANZADA SOCIEDAD LIMITADA.
INTEGRA LIFESCIENCES (IRELAND) LIMITED
Integra LifeSciences Switzerland Sàrl
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
INTEGRATED MEDICAL SYSTEMS, INC.
Internacional Farmacéutica, S.A. de C.V.
INTERNATIONAL MARKETING SPECIALIST INC
INTERNATIONAL SURGICAL PRODUCTS INC
INTERVASCULAR SAS
IP Products
ISOTIS ORTHOBIOLOGICS, INC.
ISTO TECHNOLOGIES INC
ITL ASIA PACIFIC SDN. BHD.
ITP Innovative Tomography Products GmbH
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
INTELLIGENCE TARGET SYSTEM SRL
IONIC HEALTH TECHNOLOGIES S/A
Integrity Orthopaedics, Inc
Imetric 4D Imaging Sàrl
Innoventa Medica ApS
INSPIRA TECHNOLOGIES OXY B.H.N LTD
INCISIVE TECHNOLOGIES PTY LTD
INTERNATIONAL FILTER PRODUCTS, INC.
InnoCare Urologics, LLC

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