PMA P870036S043

Device: MEDTRONIC(R)MILLENIA TM 15 CORONARY BALLOON DILATATION CATHETER
Applicant: Medtronics Interventional Vascular
PMA number: P870036
Supplement: S043
Product code: LOX
Decision date: 1997-08-12
Generic name: Catheters, transluminal coronary angioplasty, percutaneous
Approval order statement: APPROVAL FOR: A) THE ADDITIO OF 15 MM LENGTHS TO THE MILLENIA(TM) CORONARY BALLOON DILATATION CATHETER LINE; B) A CHANGE IN THE METHOD USED TO TEST FOR BURST STRENGTH OF THE BALLOONS; AND C) THE ADDITION OF THE FOLIO BALLOON SHAPING TOOL AS AN ACCESSORY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MEDTRONIC(R) MILLENIA(TM) 15 CORONARY BALLOON DILATATION CATHETER AND 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: MEDTRONIC(R)MILLENIA TM 15 CORONARY BALLOON DILATATION CATHETER
Applicant: Medtronics Interventional Vascular
PMA number: P870036
Supplement: S043
Product code: LOX
Generic name: Catheters, transluminal coronary angioplasty, percutaneous
Decision date: 1997-08-12
Decision code: APPR
Date received: 1997-03-03
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR: A) THE ADDITIO OF 15 MM LENGTHS TO THE MILLENIA(TM) CORONARY BALLOON DILATATION CATHETER LINE; B) A CHANGE IN THE METHOD USED TO TEST FOR BURST STRENGTH OF THE BALLOONS; AND C) THE ADDITION OF THE FOLIO BALLOON SHAPING TOOL AS AN ACCESSORY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MEDTRONIC(R) MILLENIA(TM) 15 CORONARY BALLOON DILATATION CATHETER AND IS INDICATED FOR BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION.