PMA P910031S001

Device
ORACLE(TM) CORONARY BALLOON DILATATION CATHETER
Applicant
Abbott Vascular Devices
PMA number
P910031
Supplement
S001
Product code
LOX
Decision date
1995-06-05
Generic name
Catheters, transluminal coronary angioplasty, percutaneous

Current openFDA PMA Record#

Device
ORACLE(TM) CORONARY BALLOON DILATATION CATHETER
Applicant
Abbott Vascular Devices
PMA number
P910031
Supplement
S001
Product code
LOX
Generic name
Catheters, transluminal coronary angioplasty, percutaneous
Decision date
1995-06-05
Decision code
APPR
Date received
1994-11-21
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material