PMA P990037S025

Device: VASCULAR SOLUTIONS D-STAT FLOWABLE HEMOSTAT
Applicant: Vascular Solutions, Inc.
PMA number: P990037
Supplement: S025
Product code: MGB
Decision date: 2007-07-17
Classification: Device, Hemostasis, Vascular
Generic name: Device, hemostasis, vascular
Approval order statement: APPROVAL FOR THE ADDITION OF THE FOLLOWING WARNING TO THE LABELING: ?THE SAFETY AND EFFECTIVENESS OF D-STAT HAS NOT BEEN ESTABLISHED FOR USE TO CONTROL BLEEDING FOLLOWING ORGAN OR TISSUE BIOPSIES. USE OF D-STAT IN THIS SITUATION HAS BEEN REPORTED TO RESULT IN PAIN, SEIZURES, BILE RETENTION, TISSUE NECROSIS, VASCULAR OCCLUSION AND DEATH.?

Current openFDA PMA Record#

Device: VASCULAR SOLUTIONS D-STAT FLOWABLE HEMOSTAT
Applicant: Vascular Solutions, Inc.
PMA number: P990037
Supplement: S025
Product code: MGB
Generic name: Device, hemostasis, vascular
Decision date: 2007-07-17
Decision code: APPR
Date received: 2007-06-14
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR THE ADDITION OF THE FOLLOWING WARNING TO THE LABELING: ?THE SAFETY AND EFFECTIVENESS OF D-STAT HAS NOT BEEN ESTABLISHED FOR USE TO CONTROL BLEEDING FOLLOWING ORGAN OR TISSUE BIOPSIES. USE OF D-STAT IN THIS SITUATION HAS BEEN REPORTED TO RESULT IN PAIN, SEIZURES, BILE RETENTION, TISSUE NECROSIS, VASCULAR OCCLUSION AND DEATH.?