PMA P890001

Device: LEOCOR SABLE(TM) PTCA CATHETER
Applicant: Leocor, Inc.
PMA number: P890001
Supplement: S018
Product code: LOX
Decision date: 1997-06-11
Generic name: Catheters, transluminal coronary angioplasty, percutaneous
Approval order statement: APPROVAL FOR A NEW MODEL PTCA CATHETER, THE SABLE(TM) PTCA CATHETER. 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: LEOCOR SABLE(TM) PTCA CATHETER
Applicant: Leocor, Inc.
PMA number: P890001
Supplement: S018
Product code: LOX
Generic name: Catheters, transluminal coronary angioplasty, percutaneous
Decision date: 1997-06-11
Decision code: APPR
Date received: 1996-09-09
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR A NEW MODEL PTCA CATHETER, THE SABLE(TM) PTCA CATHETER. 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