PMA P960043S049

Device: PERCLOSE AT 6 FRENCH SUTURE MEDIATED CLOSER (SMC) SYSTEM
Applicant: Abbott Vascular, Inc.
PMA number: P960043
Supplement: S049
Product code: MGB
Decision date: 2003-11-25
Classification: Device, Hemostasis, Vascular
Generic name: Device, hemostasis, vascular
Approval order statement: APPROVAL FOR CHANGES TO THE INSTRUCTIONS FOR USE. THESE CHANGES STRENGTHEN THE PROCEDURAL INSTRUCTIONS FOR USING THE DEVICE AND ADD A PRECAUTION TO NOT USE EXCESSIVE FORCE OR TORQUE TO ADVANCE THE DEVICE, STATING THAT SUCH ACTIONS MAY RESULT IN: "IGNIFICANT ARTERIAL DAMAGE AND/OR BREAKAGE OF THE DEVICE, WHICH MAY NECESSITATE SURGICAL REMOVAL OF THE DEVICE AND ARTERIAL REPAIR." IN ADDITION TO THESE LABELING CHANGES, YOU HAVE ALSO INDICATED THAT THE PHYSICIAN TRAINING PROTOCOL HAS BEEN REVISED TO FURTHER ADDRESS THIS CONCERN.

Current openFDA PMA Record#

Device: PERCLOSE AT 6 FRENCH SUTURE MEDIATED CLOSER (SMC) SYSTEM
Applicant: Abbott Vascular, Inc.
PMA number: P960043
Supplement: S049
Product code: MGB
Generic name: Device, hemostasis, vascular
Decision date: 2003-11-25
Decision code: APPR
Date received: 2003-10-27
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR CHANGES TO THE INSTRUCTIONS FOR USE. THESE CHANGES STRENGTHEN THE PROCEDURAL INSTRUCTIONS FOR USING THE DEVICE AND ADD A PRECAUTION TO NOT USE EXCESSIVE FORCE OR TORQUE TO ADVANCE THE DEVICE, STATING THAT SUCH ACTIONS MAY RESULT IN: "IGNIFICANT ARTERIAL DAMAGE AND/OR BREAKAGE OF THE DEVICE, WHICH MAY NECESSITATE SURGICAL REMOVAL OF THE DEVICE AND ARTERIAL REPAIR." IN ADDITION TO THESE LABELING CHANGES, YOU HAVE ALSO INDICATED THAT THE PHYSICIAN TRAINING PROTOCOL HAS BEEN REVISED TO FURTHER ADDRESS THIS CONCERN.