PMA P890001S019

Device: LEOCOR PICO-ST
Applicant: Leocor, Inc.
PMA number: P890001
Supplement: S019
Product code: LOX
Decision date: 1997-06-09
Generic name: Catheters, transluminal coronary angioplasty, percutaneous
Approval order statement: APPROVAL FOR A MODIFIED VERSION OF THE PICO-ST(TM) PTCA CATHETER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PICO-ST(TM) II PTCA 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: LEOCOR PICO-ST
Applicant: Leocor, Inc.
PMA number: P890001
Supplement: S019
Product code: LOX
Generic name: Catheters, transluminal coronary angioplasty, percutaneous
Decision date: 1997-06-09
Decision code: APPR
Date received: 1996-10-03
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR A MODIFIED VERSION OF THE PICO-ST(TM) PTCA CATHETER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PICO-ST(TM) II PTCA 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.