PMA P890001S011

Device: LEOCOR PERCUTANEOUS ANGIOPLASTY CATHETER (PTCA), MODEL 5S, LEOCOR CORFLO MODEL 7.5PT COATED PTCA, AND CORFLO HEMO PUMP
Applicant: Leocor, Inc.
PMA number: P890001
Supplement: S011
Product code: LOX
Decision date: 1996-06-13
Generic name: Catheters, transluminal coronary angioplasty, percutaneous
Approval order statement: APPROVAL FOR CHANGES IN THE INSTRUCTIONS FOR USE, THE ADDITION OF A PUMP HEAD WITH LONGER TUBING, A CHANGE IN THE CLEANING PROCESS, AND THE ADDITION OF STOPCOCKS ON THE PUMPS

Current openFDA PMA Record#

Device: LEOCOR PERCUTANEOUS ANGIOPLASTY CATHETER (PTCA), MODEL 5S, LEOCOR CORFLO MODEL 7.5PT COATED PTCA, AND CORFLO HEMO PUMP
Applicant: Leocor, Inc.
PMA number: P890001
Supplement: S011
Product code: LOX
Generic name: Catheters, transluminal coronary angioplasty, percutaneous
Decision date: 1996-06-13
Decision code: APPR
Date received: 1994-09-01
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR CHANGES IN THE INSTRUCTIONS FOR USE, THE ADDITION OF A PUMP HEAD WITH LONGER TUBING, A CHANGE IN THE CLEANING PROCESS, AND THE ADDITION OF STOPCOCKS ON THE PUMPS