Ibsa Institut Biochimique S A

FDA Filings

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

FDA Registration(s)

• Registration Number: 3008280916
• FEI Number: 3008280916
• Name: IBSA Farmaceutici Italia Srl
• Owner & Operator: IBSA Institut Biochimique SA
• Contact Address: Via al Ponte 13 ; Lugano CH-TI Ticino 6900 CH
• US Agent:
  • Christopher Jones
  • IBSA Pharma Inc.
  • 202 7536475 7005
  • chris.jones@ibsapharma.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Via Martiri di Cefalonia 2 ; Lodi (San Grato) Lombardia, 26900 IT
• Establishment Type: Manufacture Medical Device

• Registration Number: 3002864272
• FEI Number: 3002864272
• Name: IBSA INSTITUT BIOCHIMIQUE SA
• Owner & Operator: IBSA Institut Biochimique SA
• Contact Address: Via al Ponte 13 ; Lugano CH-TI Ticino 6900 CH
• US Agent:
  • Christopher Jones
  • IBSA Pharma Inc.
  • 202 7536475 7005
  • chris.jones@ibsapharma.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Via al Ponte 13 ; Lugano Ticino, 6900 CH
• Establishment Type: Develop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device Company	Device	Date
PMA P110005S009 IBSA INSTITUT BIOCHIMIQUE SA	GELSYN-3	2021-09-02
PMA P110005S008 IBSA INSTITUT BIOCHIMIQUE SA	GELSYN-3	2021-03-15
PMA P110005S007 IBSA INSTITUT BIOCHIMIQUE SA	GELSYN-3	2020-12-28
PMA P110005S006 IBSA INSTITUT BIOCHIMIQUE SA	GELSYN-3	2020-10-08
PMA P110005S005 IBSA INSTITUT BIOCHIMIQUE SA	GELSYN-3	2020-10-08
PMA P110005S004 IBSA INSTITUT BIOCHIMIQUE SA	GELSYN-3	2020-07-10
PMA P110005S003 IBSA INSTITUT BIOCHIMIQUE SA	GELSYN-3	2018-05-07
PMA P110005S002 IBSA INSTITUT BIOCHIMIQUE SA	GELSYN-3	2017-03-10
PMA P110005S001 IBSA INSTITUT BIOCHIMIQUE SA	Gel-Syn™	2016-05-23
PMN P110005 | MOZ IBSA INSTITUT BIOCHIMIQUE SA	GELSYN-3	2016-03-16
PMN P110005 | MOZ IBSA Farmaceutici Italia Srl [IBSA Institut Biochimique SA]	GELSYN-3	2016-03-16
PMA P110005 IBSA INSTITUT BIOCHIMIQUE SA	SINOVIAL (SODIUM HYALURONATE 0.8%)	2014-05-09

Similar & Related FDA Registered Companies

• 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
• 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

Related Finance Registrations

NCAGE Code	SKH73	IBSA INSTITUT BIOCHIMIQUE SA
CAGE Code	SKH73	IBSA INSTITUT BIOCHIMIQUE SA

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020083130936	Genova,Italy -> Savannah, Georgia	(ON 8 SKIDS) MEDICAL DEVICES GELSYN-3 2ML - 1 SYRINGE SET TEMPERATURE 20 CEL HS-CODE 30049000	362 CTN
2020081034168	Genova,Italy -> Savannah, Georgia	(ON 12 SKIDS) MEDICAL DEVICES GELSYN-3 2ML - 1 SYRINGE SET TEMPERATURE 20 CEL HS-CODE(S) 30049000 HS-CODE 30049000	544 BOX
2020072020634	Genova,Italy -> Savannah, Georgia	(ON 16 SKIDS) MEDICAL DEVICES GELSYN-3 2ML - 1 SYRINGE SET TEMPERATURE 20 CEL HS-CODE 30049000	718 PKG
2020040915950	Genova,Italy -> Savannah, Georgia	(ON 4 SKIDS) MEDICAL DEVICES GELSYN-3 2ML - 1 SYRINGE SET TEMPERATURE 20 CEL HS-CODE(S) 30049000 HS-CODE 30049000	183 BOX
2020032315999	Genova,Italy -> Savannah, Georgia	(ON 4 SKIDS) MEDICAL DEVICES GELSYN-3 2ML - 1 SYRINGE SET TEMPERATURE 20 CEL HS-CODE(S) 30049000 HS-CODE 30049000	183 PKG
2020030246016	Genova,Italy -> Savannah, Georgia	(ON 8 SKIDS) MEDICAL DEVICES GELSYN-3 2ML - 1 SYRINGE SET TEMPERATURE 20 CEL HS-CODE 30049000	366 PKG
2019122331216	Genova,Italy -> Savannah, Georgia	(ON 8 SKIDS) MEDICAL DEVICES GELSYN-3 2ML - 1 SYRINGE SET TEMPERATURE 20 CEL HS-CODE 30049000	362 BOX
2019111133409	Genova,Italy -> Savannah, Georgia	(ON 8 SKIDS) MEDICAL DEVICES GELSYN-3 2ML - 1 SYRINGE SET TEMPERATURE 20 CEL HS-CODE(S) 30049000 HS-CODE 30049000	363 BOX