Sophysa S A

FDA Filings

This page includes the latest FDA filings for Sophysa 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: 2087487
• FEI Number: 3005193143
• Name: SOPHYSA USA INC
• Owner & Operator: SOPHYSA SA
• Contact Address: 5 RUE GUY MOQUET ; ORSAY FR-91 Essonne 91400 FR
• Official Correspondent:
  • PAYROU Viviane
  • 033-1-69353500-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 503 E Summit Street Suite 5; Crown Point, IN 46307 US

• Registration Number: 3001587388
• FEI Number: 3001587388
• Name: SOPHYSA
• Owner & Operator: SOPHYSA SA
• Contact Address: 5 RUE GUY MOQUET ; ORSAY FR-91 Essonne 91400 FR
• Official Correspondent:
  • PAYROU Viviane
  • 033-1-69353500-x
• US Agent:
  • Steve Egan
  • Sophysa USA Inc.
  • 219 7896333
  • 219 6637741
  • steve.egan@sophysa.us
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 05 RUE GUY MOQUET ; ORSAY, CEDEX Essonne, 91400 FR
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
PMN K162108 | GWM SOPHYSA [SOPHYSA SA]	Pressio 2 ICP monitoring system	2017-07-24
PMN K162108 SOPHYSA, SA	Pressio 2 ICP Monitoring System	2017-04-17
PMN K141227 SOPHYSA SA	POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM/POLARIS ADJUSTABLE VALVE WITH SIPHONX	2015-04-02
PMN K820312 | JXG SOPHYSA [SOPHYSA SA]	SOPHYSA SHUNT	2010-05-26
PMN K024101 | JXG SOPHYSA [SOPHYSA SA]	SOPHYSA SHUNT	2010-05-26
PMN K991429 | JXG SOPHYSA [SOPHYSA SA]	SOPHYSA SHUNT	2010-05-25
PMN K990256 | JXG SOPHYSA [SOPHYSA SA]	SOPHYSA SHUNT	2010-05-25
PMN K974096 | JXG SOPHYSA [SOPHYSA SA]	SOPHYSA SHUNT	2010-05-25
PMN K960435 | JXG SOPHYSA [SOPHYSA SA]	SOPHYSA SHUNT	2010-05-25
PMN K913490 | GXR SOPHYSA [SOPHYSA SA]	SOPHYSA ACCESSORIES	2010-05-25
PMN K895524 | JXG SOPHYSA [SOPHYSA SA]	SOPHYSA SHUNT	2010-05-25
PMN K875287 | JXG SOPHYSA [SOPHYSA SA]	SOPHYSA SHUNT	2010-05-25
PMN K874508 | JXG SOPHYSA [SOPHYSA SA]	SOPHYSA SHUNT	2010-05-25
PMN K870660 | JXG SOPHYSA [SOPHYSA SA]	SOPHYSA SHUNT	2010-05-25
PMN K865075 | GYK SOPHYSA [SOPHYSA SA]	SOPHYSA ACCESSORIES	2010-05-25
PMN K853371 | JXG SOPHYSA [SOPHYSA SA]	SOPHYSA SHUNT	2010-05-25
PMN K853370 | GYK SOPHYSA [SOPHYSA SA]	SOPHYSA ACCESSORIES	2010-05-25
PMN K853369 | JXG SOPHYSA [SOPHYSA SA]	SOPHYSA SHUNT	2010-05-25
PMN K853368 | GYK SOPHYSA [SOPHYSA SA]	SOPHYSA ACCESSORIES	2010-05-25
PMN K853367 | GXR SOPHYSA [SOPHYSA SA]	SOPHYSA ACCESSORIES	2010-05-25
PMN K853366 | JXG SOPHYSA [SOPHYSA SA]	SOPHYSA SHUNT	2010-05-25
PMN K853365 | JXG SOPHYSA [SOPHYSA SA]	SOPHYSA SHUNT	2010-05-25
PMN K853364 | JXG SOPHYSA [SOPHYSA SA]	SOPHYSA SHUNT	2010-05-25
PMN K853363 | JXG SOPHYSA [SOPHYSA SA]	SOPHYSA SHUNT	2010-05-25
PMN K853362 | JXG SOPHYSA [SOPHYSA SA]	SOPHYSA SHUNT	2010-05-25
PMN K853361 | JXG SOPHYSA [SOPHYSA SA]	SOPHYSA SHUNT	2010-05-25
PMN K841553 | GYK SOPHYSA [SOPHYSA SA]	SOPHYSA ACCESSORIES	2010-05-25
PMN K830894 | JXG SOPHYSA [SOPHYSA SA]	SOPHYSA SHUNT	2010-05-25
PMN K822048 | HAO SOPHYSA [SOPHYSA SA]	SOPHYSA SHUNT	2010-05-25
PMN K820311 | JXG SOPHYSA [SOPHYSA SA]	SOPHYSA SHUNT	2010-05-25
PMN K813374 | FOZ SOPHYSA [SOPHYSA SA]	SOPHYSA CATHETERS	2010-05-25
PMN K800168 | JXG SOPHYSA [SOPHYSA SA]	SOPHYSA SHUNT	2010-05-25
PMN K792639 | GYK SOPHYSA [SOPHYSA SA]	SOPHYSA SHUNT	2010-05-25
PMN K791076 | JXG SOPHYSA [SOPHYSA SA]	SOPHYSA SHUNT	2010-05-25
PMN K791075 | JXG SOPHYSA [SOPHYSA SA]	SOPHYSA SHUNT	2010-05-25
PMN K790849 | JXG SOPHYSA [SOPHYSA SA]	SOPHYSA SHUNT	2010-05-25
PMN K790126 | JXG SOPHYSA [SOPHYSA SA]	SOPHYSA SHUNT	2010-05-25
PMN K782105 | JXG SOPHYSA [SOPHYSA SA]	SOPHYSA SHUNT	2010-05-25
PMN K781768 | JXG SOPHYSA [SOPHYSA SA]	SOPHYSA SHUNT	2010-05-25
PMN K081942 | JXG SOPHYSA [SOPHYSA SA]	SOPHYSA SHUNT	2010-05-25
PMN K033704 | JXG SOPHYSA [SOPHYSA SA]	SOPHYSA SHUNT	2010-05-25
PMN K033017 | JXG SOPHYSA [SOPHYSA SA]	SOPHYSA SHUNT	2010-05-25
PMN K030468 | JXG SOPHYSA [SOPHYSA SA]	SOPHYSA SHUNT	2010-05-25
PMN K024040 | JXG SOPHYSA [SOPHYSA SA]	SOPHYSA SHUNT	2010-05-25
PMN K021644 | JXG SOPHYSA [SOPHYSA SA]	SOPHYSA SHUNT	2010-05-25
PMN K002476 | JXG SOPHYSA [SOPHYSA SA]	SOPHYSA SHUNT	2010-05-25
PMN K000514 | JXG SOPHYSA [SOPHYSA SA]	SOPHYSA SHUNT	2010-05-25
PMN K091328 | JXG SOPHYSA [SOPHYSA SA]	Siphon X Gravitational Anti-siphon	2010-02-01
PMN K091328 SOPHYSA SA	SIPHONX GRAVITATIONAL ANTISIPHON DEVICE	2010-01-22
PMN K090342 SOPHYSA SA	POLARIS PRESSURE ADJUSTABLE VALVE, MODELS SPV, SPVA, SPVB, SPV-140, SPV-300, SPV-400	2009-08-11
PMN K031097 | JXG SOPHYSA [SOPHYSA SA]	POLARIS WITH SPECIAL PRESSURE	2008-03-12
PMN K062584 | GWM SOPHYSA [SOPHYSA SA]	PRESSIO	2007-12-21
PMN K042481 | JXG SOPHYSA [SOPHYSA SA]	POLARIS	2007-12-21
PMN K013488 | JXG SOPHYSA [SOPHYSA SA]	SOPHY	2007-12-21
PMN K062584 SOPHYSA SA	PRESSIO ICP MONITORING SYSTEM	2007-07-05
PMN K042481 SOPHYSA SA	POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM, MODELS SPV-140, SPV-300, SPV-400	2004-12-14
PMN K031097 SOPHYSA SA	POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM MODES SPV, SPVA, SPVB	2004-02-26
PMN K013488 SOPHYSA SA	SOPHY PRESSURE ADJUSTABLE VALVE SYSTEM MODEL SM8	2002-03-27
PMN K992465 SOPHYSA SA	SOPHY SU8 PRESSURE ADJUSTABLE VALVE	2000-09-21

Similar & Related FDA Registered Companies

• Sophysa USA Inc.