PMA P990037S011

Device: DIAGNOSTIC DUETT SEALING DEVICE, MODEL 2200; DIAGNOSTIC DUETT PRO SEALING DEVICE, MODEL 2210; AND D-STAT FLOWABLE HEMOS0
Applicant: Vascular Solutions, Inc.
PMA number: P990037
Supplement: S011
Product code: MGB
Decision date: 2002-09-23
Generic name: Device, hemostasis, vascular
Approval order statement: CHANGE IN THE ENDOTOXIN EXTRACTION PROCEDURE FOR TESTING THE SEALING AND HEMOSTASIS DEVICES.

Current openFDA PMA Record#

Device: DIAGNOSTIC DUETT SEALING DEVICE, MODEL 2200; DIAGNOSTIC DUETT PRO SEALING DEVICE, MODEL 2210; AND D-STAT FLOWABLE HEMOS0
Applicant: Vascular Solutions, Inc.
PMA number: P990037
Supplement: S011
Product code: MGB
Generic name: Device, hemostasis, vascular
Decision date: 2002-09-23
Decision code: OK30
Date received: 2002-08-26
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE IN THE ENDOTOXIN EXTRACTION PROCEDURE FOR TESTING THE SEALING AND HEMOSTASIS DEVICES.