PMA P990037S013

Device: DUETT SEALING DEVICE
Applicant: Vascular Solutions, Inc.
PMA number: P990037
Supplement: S013
Product code: MGB
Decision date: 2003-02-21
Classification: Device, Hemostasis, Vascular
Generic name: Device, hemostasis, vascular
Approval order statement: CHANGE IN THE MANUFACTURING PROCEDURES TO PROPOSE REDUCTION IN POUCH AND SEAL STRENGTH TOLERANCE, TOLERANCE CHANGE TO THE KNOB BASE AND HUB BASE, CHANGES TO THE SEALING ACHANGE IN THE MANUFACTURING PROCEDURES TO PROPOSE REDUCTION IN POUCH AND SEAL STRENGTH TOLERANCE, TOLERANCE CHANGE TO THE KNOB BASE AND HUB BASE, CHANGES TO THE SEALING AND PILOT BALLOONS, SLEEVE MARKING CHANGES AND REDUCTION IN THE BIOBURDEN MONITORING LIMITS FOR THE DUETT FAMILY OF SEALING DEVICES.ND PILOT BALLOONS, SLEEVE MARKING CHANGES AND REDUCTION IN THE BIOBURDEN MONITORING LIMITS FOR THE DUETT FAMILY OF SEALING DEVICES.

Current openFDA PMA Record#

Device: DUETT SEALING DEVICE
Applicant: Vascular Solutions, Inc.
PMA number: P990037
Supplement: S013
Product code: MGB
Generic name: Device, hemostasis, vascular
Decision date: 2003-02-21
Decision code: OK30
Date received: 2003-01-23
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE IN THE MANUFACTURING PROCEDURES TO PROPOSE REDUCTION IN POUCH AND SEAL STRENGTH TOLERANCE, TOLERANCE CHANGE TO THE KNOB BASE AND HUB BASE, CHANGES TO THE SEALING ACHANGE IN THE MANUFACTURING PROCEDURES TO PROPOSE REDUCTION IN POUCH AND SEAL STRENGTH TOLERANCE, TOLERANCE CHANGE TO THE KNOB BASE AND HUB BASE, CHANGES TO THE SEALING AND PILOT BALLOONS, SLEEVE MARKING CHANGES AND REDUCTION IN THE BIOBURDEN MONITORING LIMITS FOR THE DUETT FAMILY OF SEALING DEVICES.ND PILOT BALLOONS, SLEEVE MARKING CHANGES AND REDUCTION IN THE BIOBURDEN MONITORING LIMITS FOR THE DUETT FAMILY OF SEALING DEVICES.