M D L S R L

FDA Filings

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

FDA Registration(s)

• Registration Number: 3004749705
• FEI Number: 3004749705
• Name: Valerie Followell
• Owner & Operator: M.D.L. S.r.l.
• Contact Address: Via Tavani 1/a ; Delebio (So) IT-SO Sondrio 23014 IT
• Official Correspondent:
  • Marcello Dell 'Oca
  • 039-0342-682130-x
• US Agent:
  • Valerie Followell
  • Followell Compliance Consultants LLC
  • 847 4006187
  • valeriefollowell@outlook.com
• Importing Logistics Registration:
  • Importer: MDL USA CORPORATION
  • Address: 66W FLAGLER ST STE 1002 ; Miami, FL 33130 UNITED STATES
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 8049 Tripp Avenue ; Skokie, IL 60076 US
• Establishment Type: Manufacture Medical Device

FDA Owner/Operator Registration

FDA Filings

Device Company	Device	Date
GUDID 28056138586721 M.D.L. S.R.L.	Themy TY1810	2021-06-01
GUDID 28052440101652 M.D.L. SRL	Themy TY1610	2020-12-03
GUDID 08058341219232 M.D.L. SRL	Intro PT19140	2019-10-07
GUDID 08058341219218 M.D.L. SRL	Intro PT19075	2019-10-07
GUDID 08058341216682 M.D.L. SRL	Intro PT1705	2019-10-07
GUDID 08058341216354 M.D.L. SRL	Intro PT13075	2019-10-07
GUDID 08058341212561 M.D.L. SRL	Intro PT1305	2019-10-07
GUDID 08058341211151 M.D.L. SRL	Intro PT17075	2019-10-07
GUDID 08055271570198 M.D.L. SRL	INTRO PT15044	2019-10-07
GUDID 08052440109029 M.D.L. SRL	Intro PT17140	2019-10-07
GUDID 08052440109012 M.D.L. SRL	Intro PT17110	2019-10-07
GUDID 08052440109005 M.D.L. SRL	Intro PT17095	2019-10-07
GUDID 08052440108992 M.D.L. SRL	Intro PT15140	2019-10-07
GUDID 08052440108985 M.D.L. SRL	Intro PT15110	2019-10-07
GUDID 08052440108978 M.D.L. SRL	Intro PT15095	2019-10-07
GUDID 08052440103522 M.D.L. SRL	Intro PT13044	2019-10-07
GUDID 08052440100750 M.D.L. SRL	Intro PT17044	2019-10-07
GEA Valerie Followell [M.D.L. S.r.l.]	Liposuction cannula LP25180111, LP0907119, LP1718123	2019-05-28
PMN K160316 | KNW Valerie Followell [M.D.L. S.r.l.]	Themy Automatic Disposable Biopsy Device	2016-12-27
PMN K160316 | KNW Valerie Followell [M.D.L. S.r.l.]	SemiCut Semi-automatic Biopsy Needle	2016-12-27
PMN K160316 | KNW Valerie Followell [M.D.L. S.r.l.]	Palium Automatic Reusable Biopsy Device	2016-12-27
PMN K160316 | KNW Valerie Followell [M.D.L. S.r.l.]	MDL Biopsy Needle for use with Palium Automatic Reusable Biopsy Device	2016-12-27
PMN K160316 | KNW Valerie Followell [M.D.L. S.r.l.]	INTRO Coaxial Introducer Needle	2016-12-27
PMN K160316 | KNW Valerie Followell [M.D.L. S.r.l.]	EasyCut Semi-automatic Biopsy Needle	2016-12-27
PMN K160316 | FCG Valerie Followell [M.D.L. S.r.l.]	Themy Automatic Disposable Biopsy Device	2016-12-27
PMN K160316 | FCG Valerie Followell [M.D.L. S.r.l.]	SemiCut Semi-automatic Biopsy Needle	2016-12-27
PMN K160316 | FCG Valerie Followell [M.D.L. S.r.l.]	Palium Automatic Reusable Biopsy Device	2016-12-27
PMN K160316 | FCG Valerie Followell [M.D.L. S.r.l.]	MDL Biopsy Needle for use with Palium Automatic Reusable Biopsy Device	2016-12-27
PMN K160316 | FCG Valerie Followell [M.D.L. S.r.l.]	INTRO Coaxial Introducer Needle	2016-12-27
PMN K160316 | FCG Valerie Followell [M.D.L. S.r.l.]	EasyCut Semi-automatic Biopsy Needle	2016-12-27
PMN K160316 M.D.L. S.r.l.	SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy Device, Palium Automatic Reusable Biopsy Device, EasyCut Semi-automatic Biopsy Needle, MDL Biopsy And Coaxial Introducer Needles	2016-10-27
MJG Valerie Followell [M.D.L. S.r.l.]	Palium Needle	2015-10-05
MJG Valerie Followell [M.D.L. S.r.l.]	INTRO	2015-10-05
MJG Valerie Followell [M.D.L. S.r.l.]	HandCut	2015-10-05
MJG Valerie Followell [M.D.L. S.r.l.]	FastCutS	2015-10-05
MJG Valerie Followell [M.D.L. S.r.l.]	FastCutP	2015-10-05
MJG Valerie Followell [M.D.L. S.r.l.]	FastCutM	2015-10-05
MJG Valerie Followell [M.D.L. S.r.l.]	FastCutE	2015-10-05
MJG Valerie Followell [M.D.L. S.r.l.]	EasyLock	2015-10-05
GDF Valerie Followell [M.D.L. S.r.l.]	RePoMark	2015-10-05
GDF Valerie Followell [M.D.L. S.r.l.]	RePo Mark	2015-10-05
GDF Valerie Followell [M.D.L. S.r.l.]	MarkSlim	2015-10-05
GDF Valerie Followell [M.D.L. S.r.l.]	Mark	2015-10-05
GDF Valerie Followell [M.D.L. S.r.l.]	AutoMark	2015-10-05
GAA Valerie Followell [M.D.L. S.r.l.]	CytoCut	2015-10-05
DWO Valerie Followell [M.D.L. S.r.l.]	PRESSTO	2014-10-21
DWO Valerie Followell [M.D.L. S.r.l.]	PICKUP	2014-10-21
DWO Valerie Followell [M.D.L. S.r.l.]	PENBONE	2014-10-21
DWO Valerie Followell [M.D.L. S.r.l.]	OSTEOJ	2014-10-21
DWO Valerie Followell [M.D.L. S.r.l.]	JAMBLU	2014-10-21
DWO Valerie Followell [M.D.L. S.r.l.]	ILLY	2014-10-21
DWO Valerie Followell [M.D.L. S.r.l.]	HARVEST	2014-10-21

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• Medtronic Vascular3576 Unocal Placesanta Rosa, CA 95403 PMA NumberP100021 Supplement NumberS111 Date Received11/29/2022 Decision Date12/01/2022 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 NumberS064 Date Received11/29/2022 Decision Date12/01/2022 Product Code NIQ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Medtronic, Inc.710 Medtronic Parkwayminneapolis,, MN 55432 PMA NumberP130021 Supplement NumberS128 Date Received11/29/2022 Decision Date12/01/2022 Product Code NPT  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• MEDTRONIC Inc.3576 Unocal Plsanta Rosa, CA 95403 PMA NumberP140010 Supplement NumberS071 Date Received11/29/2022 Decision Date12/01/2022 Product Code ONU  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Medtronic, Inc.710 Medtronic Parkwayminneapolis,, MN 55432 PMA NumberP130021 Supplement NumberS129 Date Received11/30/2022 Decision Date12/01/2022 Product Code NPT  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• MERZ NORTH AMERICA, INC4133 Courtney Roadsuite 10franksville, WI 53126 PMA NumberP050052 Supplement NumberS140 Date Received11/01/2022 Decision Date11/30/2022 Product Code LMH  Advisory Committee General & Plastic Surgery 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 NumberS109 Date Received11/01/2022 Decision Date11/30/2022 Product Code MIH  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• MERZ NORTH AMERICA, INC4133 Courtney Roadsuite 10franksville, WI 53126 PMA NumberP040047 Supplement NumberS067 Date Received11/01/2022 Decision Date11/30/2022 Product Code LNM  Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• MERZ NORTH AMERICA, INC4133 Courtney Roadsuite 10franksville, WI 53126 PMA NumberP050037 Supplement NumberS119 Date Received11/01/2022 Decision Date11/30/2022 Product Code LMH  Advisory Committee General & Plastic Surgery 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 NumberS054 Date Received11/18/2022 Decision Date11/28/2022 Product Code MIH  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 Nemvs83mounds View, MN 55112 PMA NumberP140017 Supplement NumberS023 Date Received11/16/2022 Decision Date11/28/2022 Product Code NPV  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 NumberP030036 Supplement NumberS141 Date Received11/21/2022 Decision Date11/28/2022 Product Code NVN  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 NumberS163 Date Received11/21/2022 Decision Date11/28/2022 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 NumberP160043 Supplement NumberS063 Date Received11/18/2022 Decision Date11/28/2022 Product Code NIQ  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 NumberS110 Date Received11/18/2022 Decision Date11/28/2022 Product Code MIH  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 NumberS127 Date Received11/18/2022 Decision Date11/28/2022 Product Code NPT  Advisory Committee Cardiovascular 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 NumberS376 Date Received11/08/2022 Decision Date11/22/2022 Product Code EZW  Advisory Committee Gastroenterology/Urology 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 NumberP030036 Supplement NumberS140 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, 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 Inc.8200 Coral Sea Street Nems Mv S11mounds View, MN 55112 PMA NumberP950024 Supplement NumberS105 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, Inc8200 Coral Sea Street Nemounds View, MN 55112 PMA NumberP090013 Supplement NumberS325 Date Received11/16/2022 Decision Date11/22/2022 Product Codes NVN LWP  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 NumberP060039 Supplement NumberS112 Date Received11/16/2022 Decision Date11/22/2022 Product Code OJX  Advisory Committee Cardiovascular 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 NumberS533 Date Received11/14/2022 Decision Date11/22/2022 Product Code LGW  Advisory Committee Neurology 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 NumberP830061 Supplement NumberS210 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 NEUROMODULATION7000 Central Avenue, N.e.minneapolis, MN 55432 PMA NumberP970004 Supplement NumberS377 Date Received11/14/2022 Decision Date11/22/2022 Product Code EZW  Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• MERZ NORTH AMERICA, INC4133 Courtney Roadsuite 10franksville, WI 53126 PMA NumberP050052 Supplement NumberS139 Date Received11/01/2022 Decision Date11/22/2022 Product Code LMH  Advisory Committee General & Plastic Surgery Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• MERZ NORTH AMERICA, INC4133 Courtney Roadsuite 10franksville, WI 53126 PMA NumberP050037 Supplement NumberS118 Date Received11/01/2022 Decision Date11/22/2022 Product Code LMH  Advisory Committee General & Plastic Surgery Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• MERZ NORTH AMERICA, INC4133 Courtney Roadsuite 10franksville, WI 53126 PMA NumberP040047 Supplement NumberS066 Date Received11/01/2022 Decision Date11/22/2022 Product Code LNM  Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• MEDTRONIC NEUROMODULATION7000 Central Avenue Nems Rcw225minneapolis, MN 55432 PMA NumberP080025 Supplement NumberS272 Date Received11/14/2022 Decision Date11/22/2022 Product Code QON  Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• MEDTRONIC Inc.8200 Coral Sea Street Nems Mv S11mounds View, MN 55112 PMA NumberP010015 Supplement NumberS510 Date Received11/16/2022 Decision Date11/22/2022 Product Code LWP  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 NumberP010015 Supplement NumberS511 Date Received11/16/2022 Decision Date11/22/2022 Product Code LWP  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
• MEDTRONIC Inc.8200 Coral Sea Street Nems Mv S11mounds View, MN 55112 PMA NumberP980035 Supplement NumberS735 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
• MEDTRONIC Inc.8200 Coral Sea Street Nems Mv S11mounds View, MN 55112 PMA NumberP920015 Supplement NumberS273 Date Received11/16/2022 Decision Date11/22/2022 Product Code NVY  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• MEDTRONIC Inc.7000 Central Avenue Neminneapolis, MN 55432-3576 PMA NumberP960009 Supplement NumberS442 Date Received11/08/2022 Decision Date11/22/2022 Product Code MHY  Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• MEDTRONIC Inc.8200 Coral Sea Streetms Mvs11mounds View, MN 55112 PMA NumberP980050 Supplement NumberS139 Date Received11/16/2022 Decision Date11/22/2022 Product Code LWS  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• MEDTRONIC NEUROMODULATION7000 Central Avenue Nems Rcw225minneapolis, MN 55432 PMA NumberP080025 Supplement NumberS271 Date Received11/08/2022 Decision Date11/22/2022 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 NumberS532 Date Received11/08/2022 Decision Date11/22/2022 Product Code LGW  Advisory Committee Neurology 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 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.710 Medtronic Parkway Neminneapolis, MN 55432 PMA NumberP080006 Supplement NumberS173 Date Received11/16/2022 Decision Date11/22/2022 Product Code OJX  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 N.e.mounds View, MN 55112 PMA NumberP890003 Supplement NumberS458 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
• 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
• MEDTRONIC Inc.7000 Central Avenue Neminneapolis, MN 55432-3576 PMA NumberP960009 Supplement NumberS443 Date Received11/14/2022 Decision Date11/22/2022 Product Code MHY  Advisory Committee Neurology 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.ms Mvs11mounds View, MN 55112 PMA NumberP980016 Supplement NumberS841 Date Received11/16/2022 Decision Date11/22/2022 Product Code LWS  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 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
• 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
• 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
• MENTOR WORLDWIDE LLC33 Technology Driveirvine, CA 92618 PMA NumberP990075 Supplement NumberS054 Date Received05/10/2022 Decision Date11/16/2022 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
• MYRIAD GENETIC LABORATORIES320 Wakara Waysalt Lake City, UT 84108 PMA NumberP140020 Supplement NumberS025 Date Received10/18/2022 Decision Date11/16/2022 Product Code PJG  Advisory Committee Pathology Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
• MEDTRONIC 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 Inc.7000 Central Avenue Neminneapolis, MN 55432-3576 PMA NumberP960009 Supplement NumberS441 Date Received10/18/2022 Decision Date11/16/2022 Product Code MHY  Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
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