PMA P990037S031

Device: VASCULAR SOLUTIONS DUETT SEALING DEVICE
Applicant: Vascular Solutions, Inc.
PMA number: P990037
Supplement: S031
Product code: MGB
Decision date: 2010-09-15
Classification: Device, Hemostasis, Vascular
Generic name: Device, hemostasis, vascular
Approval order statement: APPROVAL FOR A MANUFACTURING SITE LOCATED AT STERIS ISOMEDIX SERVICES, INC., MINNEAPOLIS, MINNESOTA TO PERFORM THE ETHYLENE OXIDE PRE-TREATMENT STEP OF THE BULK COLLAGEN COMPONENT OF THE SUBJECT DEVICE.

Current openFDA PMA Record#

Device: VASCULAR SOLUTIONS DUETT SEALING DEVICE
Applicant: Vascular Solutions, Inc.
PMA number: P990037
Supplement: S031
Product code: MGB
Generic name: Device, hemostasis, vascular
Decision date: 2010-09-15
Decision code: APPR
Date received: 2010-07-30
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A MANUFACTURING SITE LOCATED AT STERIS ISOMEDIX SERVICES, INC., MINNEAPOLIS, MINNESOTA TO PERFORM THE ETHYLENE OXIDE PRE-TREATMENT STEP OF THE BULK COLLAGEN COMPONENT OF THE SUBJECT DEVICE.