PMA P930038S054

Device: ANGIO-SEAL EVOLUTION VASCULAR CLOSURE DEVICE
Applicant: Terumo Medical Corporation
PMA number: P930038
Supplement: S054
Product code: MGB
Decision date: 2008-03-18
Classification: Device, Hemostasis, Vascular
Generic name: Device, hemostasis, vascular
Approval order statement: APPROVAL FOR DEVICE MODIFICATIONS TO THE ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE INCLUDING UTILIZING AN AUTOMATED COLLAGEN COMPACTION MECHANISM FOR EASE OF USE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ANGIO-SEAL EVOLUTION VASCULAR CLOSURE DEVICE AND IS INDICATED FOR USE IN CLOSING AND IN REDUCING TIME TO HEMOSTASIS AT THE FEMORAL ARTERIAL PUNCTURE SITE IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC ANGIOGRAPHY OR PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) PROCEDURES USING AN 8 FRENCH OR SMALLER PROCEDURAL SHEATH.

Current openFDA PMA Record#

Device: ANGIO-SEAL EVOLUTION VASCULAR CLOSURE DEVICE
Applicant: Terumo Medical Corporation
PMA number: P930038
Supplement: S054
Product code: MGB
Generic name: Device, hemostasis, vascular
Decision date: 2008-03-18
Decision code: APPR
Date received: 2008-01-22
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR DEVICE MODIFICATIONS TO THE ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE INCLUDING UTILIZING AN AUTOMATED COLLAGEN COMPACTION MECHANISM FOR EASE OF USE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ANGIO-SEAL EVOLUTION VASCULAR CLOSURE DEVICE AND IS INDICATED FOR USE IN CLOSING AND IN REDUCING TIME TO HEMOSTASIS AT THE FEMORAL ARTERIAL PUNCTURE SITE IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC ANGIOGRAPHY OR PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) PROCEDURES USING AN 8 FRENCH OR SMALLER PROCEDURAL SHEATH.