PMA P990037S020

Device: DUETT PRO MODEL 1010 AND DIAGNOSTIC DUETT PRO MODEL 2210
Applicant: Vascular Solutions, Inc.
PMA number: P990037
Supplement: S020
Product code: MGB
Decision date: 2003-07-11
Classification: Device, Hemostasis, Vascular
Generic name: Device, hemostasis, vascular
Approval order statement: CHANGE IN THE TENSILE TEST METHOD, WHICH TESTS THE FUNCTIONALITY OF THE CATHETER USING A METHOD THAT ALIGNS IT WITH THE REQUIRED SPECIFICATION.

Current openFDA PMA Record#

Device: DUETT PRO MODEL 1010 AND DIAGNOSTIC DUETT PRO MODEL 2210
Applicant: Vascular Solutions, Inc.
PMA number: P990037
Supplement: S020
Product code: MGB
Generic name: Device, hemostasis, vascular
Decision date: 2003-07-11
Decision code: OK30
Date received: 2003-06-18
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE IN THE TENSILE TEST METHOD, WHICH TESTS THE FUNCTIONALITY OF THE CATHETER USING A METHOD THAT ALIGNS IT WITH THE REQUIRED SPECIFICATION.