PMA P990037S030

Device: VASCULAR SOLUTIONS DUETT SEALING DEVICE
Applicant: Vascular Solutions, Inc.
PMA number: P990037
Supplement: S030
Product code: MGB
Decision date: 2010-05-07
Classification: Device, Hemostasis, Vascular
Generic name: Device, hemostasis, vascular
Approval order statement: CHANGE IN THE QUALITY CONTROL DEVICE USED TO MONITOR THE STERILIZATION PROCESS FROM AN IN-HOUSE MANUFACTURED STERILIZATION PROCESS CONTROL DEVICE (SPCD) TO A COMMERCIALLY PURCHASED PCD.

Current openFDA PMA Record#

Device: VASCULAR SOLUTIONS DUETT SEALING DEVICE
Applicant: Vascular Solutions, Inc.
PMA number: P990037
Supplement: S030
Product code: MGB
Generic name: Device, hemostasis, vascular
Decision date: 2010-05-07
Decision code: OK30
Date received: 2010-04-09
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE IN THE QUALITY CONTROL DEVICE USED TO MONITOR THE STERILIZATION PROCESS FROM AN IN-HOUSE MANUFACTURED STERILIZATION PROCESS CONTROL DEVICE (SPCD) TO A COMMERCIALLY PURCHASED PCD.