POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM MODES SPV, SPVA, SPVB

Shunt, Central Nervous System And Components

SOPHYSA SA

The following data is part of a premarket notification filed by Sophysa Sa with the FDA for Polaris Pressure Adjustable Valve System Modes Spv, Spva, Spvb.

Pre-market Notification Details

• Device ID: K031097
• 510k Number: K031097
• Device Name: POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM MODES SPV, SPVA, SPVB
• Classification: Shunt, Central Nervous System And Components
• Applicant: SOPHYSA SA 70 WALNUT ST. Wellesley, MA 02481
• Contact: Jacqueline E Masse
• Correspondent: Jacqueline E Masse; SOPHYSA SA 70 WALNUT ST. Wellesley, MA 02481
• Product Code: JXG
• CFR Regulation Number: 882.5550 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-04-07
• Decision Date: 2004-02-26
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
03760124132144	K031097	000
03760124132137	K031097	000
03760124132120	K031097	000
03760124132113	K031097	000
03760124132106	K031097	000