PMA P910031S021

Device: JOMED JOCATH GLADIATOR PTCA CATHETER (OTW)
Applicant: Abbott Vascular Devices
PMA number: P910031
Supplement: S021
Product code: LOX
Decision date: 2003-08-01
Generic name: Catheters, transluminal coronary angioplasty, percutaneous
Approval order statement: APPROVAL FOR THE JOMED JOCATH GLADIATOR PTCA CATHETER (OTW). THE DEVICE IS INDICATED FOR BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION.

Current openFDA PMA Record#

Device: JOMED JOCATH GLADIATOR PTCA CATHETER (OTW)
Applicant: Abbott Vascular Devices
PMA number: P910031
Supplement: S021
Product code: LOX
Generic name: Catheters, transluminal coronary angioplasty, percutaneous
Decision date: 2003-08-01
Decision code: APPR
Date received: 2001-12-06
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE JOMED JOCATH GLADIATOR PTCA CATHETER (OTW). THE DEVICE IS INDICATED FOR BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION.