F G P S R L

FDA Filings

This page includes the latest FDA filings for F G P 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	3003981946
FEI Number	3003981946
Name	F.G.P. S.R.L.
Owner & Operator	F.G.P.S.R.L.
Contact Address	Via Staffali 16/B Dossobuono IT-VR Verona 37062 IT
US Agent	John Cody MEDI USA, LP 336 4494440 211 888 5704554 Johnc@mediusa.com
Registration Status	1
Initial Importer	N
Registration Expiration	2020-04-25
Registration Address	VIA STAFFALI 16/B DOSSOBUONO Verona, 37062 IT
Establishment Type	Manufacture Medical Device

FDA Owner/Operator Registration

FDA Filings

Device Company	Device	Date
ITW F.G.P. S.R.L. [F.G.P.S.R.L.]	D.T3-CVT ankle brace	2019-11-06
ITW F.G.P. S.R.L. [F.G.P.S.R.L.]	CVO-750 walker boot	2019-11-06
IQI F.G.P. S.R.L. [F.G.P.S.R.L.]	PFO 100 wrist brace	2003-03-10
IQI F.G.P. S.R.L. [F.G.P.S.R.L.]	M-4	2003-03-10
IQI F.G.P. S.R.L. [F.G.P.S.R.L.]	M-3	2003-03-10
IQI F.G.P. S.R.L. [F.G.P.S.R.L.]	M-2	2003-03-10
IQI F.G.P. S.R.L. [F.G.P.S.R.L.]	Epicomed	2003-03-10
IQE F.G.P. S.R.L. [F.G.P.S.R.L.]	SPINOMED	2003-03-10
IQE F.G.P. S.R.L. [F.G.P.S.R.L.]	SCA-101 scaphomed	2003-03-10

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Ferrosan Meidcal Devices A/Ssydmarken 5soeborg 08876 PMA NumberP990004 Supplement NumberS056 Date Received07/01/2022 Decision Date01/31/2023 Product Code LMF 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
Ferrosan Meidcal Devices A/Ssydmarken 5soeborg 08876 PMA NumberP990004 Supplement NumberS055 Date Received06/27/2022 Decision Date12/21/2022 Product Code LMF 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
Foundation Medicine Inc.150 Second Streetcambridge, MA 02141 PMA NumberP190032 Supplement NumberS008 Date Received09/26/2022 Decision Date12/19/2022 Product Code PQP Advisory Committee Pathology Supplement Typereal-time Process Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
Foundation Medicine, Inc.150 Second Streetcambridge, MA 02141 PMA NumberP200006 Supplement NumberS003 Date Received09/30/2022 Decision Date10/28/2022 Product Code PQP Advisory Committee Pathology Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No
Foundation Medicine, Inc.150 Second Street, 1st Floorcambridge, MA 02141 PMA NumberP170019 Supplement NumberS038 Date Received08/29/2022 Decision Date09/27/2022 Product Code PQP Advisory Committee Pathology Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
Foundation Medicine, Inc.150 Second Streetcambridge, MA 02141 PMA NumberP200006 Supplement NumberS002 Date Received08/22/2022 Decision Date09/21/2022 Product Code PQP Advisory Committee Pathology Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
Foundation Medicine, Inc.150 Second Streetcambridge, MA 02141 PMA NumberP200016 Supplement NumberS001 Date Received08/22/2022 Decision Date09/21/2022 Product Code PQP Advisory Committee Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
Foundation Medicine Inc.150 Second Streetcambridge, MA 02141 PMA NumberP190032 Supplement NumberS007 Date Received08/29/2022 Decision Date09/21/2022 Product Code PQP Advisory Committee Pathology Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
Foundation Medicine Inc.150 Second Streetcambridge, MA 02141 PMA NumberP190032 Supplement NumberS006 Date Received08/22/2022 Decision Date09/21/2022 Product Code PQP Advisory Committee Pathology Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
Foundation Medicine, Inc.150 Second Street, 1st Floorcambridge, MA 02141 PMA NumberP170019 Supplement NumberS035 Date Received06/09/2022 Decision Date07/08/2022 Product Code PQP Advisory Committee Pathology Supplement Typenormal 180 Day Track No User Fee Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
Foundation Medicine Inc.150 Second Streetcambridge, MA 02141 PMA NumberP190032 Supplement NumberS003 Date Received10/28/2021 Decision Date05/25/2022 Product Code PQP Advisory Committee Pathology Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
FLOWONIX MEDICAL, INC.500 International Drivesuite 200mt.olive, NJ 07828 PMA NumberP080012 Supplement NumberS072 Date Received03/30/2022 Decision Date04/28/2022 Product Code LKK Advisory Committee General Hospital Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
Foundation Medicine, Inc.150 Second Street, 1st Floorcambridge, MA 02141 PMA NumberP170019 Supplement NumberS034 Date Received03/18/2022 Decision Date04/13/2022 Product Code PQP Advisory Committee Pathology Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No
Ferrosan Meidcal Devices A/Ssydmarken 5soeborg 08876 PMA NumberP990004 Supplement NumberS054 Date Received03/07/2022 Decision Date04/06/2022 Product Code LMF Advisory Committee General & Plastic Surgery Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Foundation Medicine, Inc.150 Second Street, 1st Floorcambridge, MA 02141 PMA NumberP170019 Supplement NumberS033 Date Received12/23/2021 Decision Date03/16/2022 Product Code PQP Advisory Committee Pathology Supplement Typereal-time Process Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
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