PMA P050043S005

Device: FEMORAL INTRODUCER SHEATH & HEMOSTASIS (FISH) DEVICE
Applicant: Morris Innovative Research, Inc.
PMA number: P050043
Supplement: S005
Product code: MGB
Decision date: 2011-07-11
Classification: Device, Hemostasis, Vascular
Generic name: Device, hemostasis, vascular
Approval order statement: APPROVAL FOR: ADDING A CUFF STABILIZER SHEATH, MODIFYING THE SUTURE INDICATOR KNOTS AND UPDATING LABELING. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME FISH- SP ADVANCED COMPRESSION DEVICE AND IS INDICATED FOR "...FOR HEMOSTATIC CLOSURE OF FEMORAL ARTERY ACCESS SITES. THE SYSTEM IS INDICATED FOR USE IN REDUCING TIME TO HEMOSTASIS AND TIME TO AMBULATION IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC PROCEDURES USING 5, 6, 7 OR 8 FRENCH PROCEDURAL SHEATHS."

Current openFDA PMA Record#

Device: FEMORAL INTRODUCER SHEATH & HEMOSTASIS (FISH) DEVICE
Applicant: Morris Innovative Research, Inc.
PMA number: P050043
Supplement: S005
Product code: MGB
Generic name: Device, hemostasis, vascular
Decision date: 2011-07-11
Decision code: APPR
Date received: 2011-05-12
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR: ADDING A CUFF STABILIZER SHEATH, MODIFYING THE SUTURE INDICATOR KNOTS AND UPDATING LABELING. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME FISH- SP ADVANCED COMPRESSION DEVICE AND IS INDICATED FOR "...FOR HEMOSTATIC CLOSURE OF FEMORAL ARTERY ACCESS SITES. THE SYSTEM IS INDICATED FOR USE IN REDUCING TIME TO HEMOSTASIS AND TIME TO AMBULATION IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC PROCEDURES USING 5, 6, 7 OR 8 FRENCH PROCEDURAL SHEATHS."