PMA P960043S045

Device: PERCLOSE AT 6 FRENCH SUTURE MEDIATED CLOSER (SMC) SYSTEM, AND PERCLOSE AT MONOFILAMENT 6 FRENCH SUTURE MEDIATED CLOSER M
Applicant: Abbott Vascular, Inc.
PMA number: P960043
Supplement: S045
Product code: MGB
Decision date: 2003-05-16
Classification: Device, Hemostasis, Vascular
Generic name: Device, hemostasis, vascular
Approval order statement: APPROVAL FOR INTRODUCING A NEW TEST METHOD TO EVALUATE THE LINK TO CUFF JOINT STRENGTH.

Current openFDA PMA Record#

Device: PERCLOSE AT 6 FRENCH SUTURE MEDIATED CLOSER (SMC) SYSTEM, AND PERCLOSE AT MONOFILAMENT 6 FRENCH SUTURE MEDIATED CLOSER M
Applicant: Abbott Vascular, Inc.
PMA number: P960043
Supplement: S045
Product code: MGB
Generic name: Device, hemostasis, vascular
Decision date: 2003-05-16
Decision code: APPR
Date received: 2003-04-18
Supplement type: Special (Immediate Track)
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR INTRODUCING A NEW TEST METHOD TO EVALUATE THE LINK TO CUFF JOINT STRENGTH.