PMA P910031S003

Device
CATHSCANNER ORACLE MICRO PTCA CATHETER
Applicant
Abbott Vascular Devices
PMA number
P910031
Supplement
S003
Product code
LOX
Decision date
1995-12-07
Generic name
Catheters, transluminal coronary angioplasty, percutaneous
Approval order statement
APPROVAL FOR THE ENDOSONICS ORACLE FOCUS PTCA CATHETER, AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAME ENDOSONICS ORACLE FOCUS PTCA CATHETER

Current openFDA PMA Record#

Device
CATHSCANNER ORACLE MICRO PTCA CATHETER
Applicant
Abbott Vascular Devices
PMA number
P910031
Supplement
S003
Product code
LOX
Generic name
Catheters, transluminal coronary angioplasty, percutaneous
Decision date
1995-12-07
Decision code
APPR
Date received
1995-06-02
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR THE ENDOSONICS ORACLE FOCUS PTCA CATHETER, AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAME ENDOSONICS ORACLE FOCUS PTCA CATHETER