PMA P890001S015

Device
LEOCOR PICO RUNNER(TM) PTCA CATHETER
Applicant
Leocor, Inc.
PMA number
P890001
Supplement
S015
Product code
LOX
Decision date
1996-06-07
Generic name
Catheters, transluminal coronary angioplasty, percutaneous
Approval order statement
APPROVAL FOR AN EXTENSION OF THE LEOCOR PICO RUNNER PTCA CATHETER LINE TO INCLUDE A 4.0MM BALLOON DIAMETER

Current openFDA PMA Record#

Device
LEOCOR PICO RUNNER(TM) PTCA CATHETER
Applicant
Leocor, Inc.
PMA number
P890001
Supplement
S015
Product code
LOX
Generic name
Catheters, transluminal coronary angioplasty, percutaneous
Decision date
1996-06-07
Decision code
APPR
Date received
1995-12-01
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR AN EXTENSION OF THE LEOCOR PICO RUNNER PTCA CATHETER LINE TO INCLUDE A 4.0MM BALLOON DIAMETER