PMA P870036S042

Device
MEDTRONIC(R) MS2(TM) BALLOON SHAPING TOOL
Applicant
Medtronics Interventional Vascular
PMA number
P870036
Supplement
S042
Product code
LOX
Decision date
1997-07-28
Generic name
Catheters, transluminal coronary angioplasty, percutaneous
Approval order statement
APPROVAL FOR THE ADDITION OF AN ACCESSORY DEVICE, THE FOLIO BALLOON SHAPING TOOL, TO YOUR CURRENTLY MARKETED LINE OF MEDTRONIC (R) MILLENIA(TM) CORONARY BALLOON DILATATION CATHETERS.

Current openFDA PMA Record#

Device
MEDTRONIC(R) MS2(TM) BALLOON SHAPING TOOL
Applicant
Medtronics Interventional Vascular
PMA number
P870036
Supplement
S042
Product code
LOX
Generic name
Catheters, transluminal coronary angioplasty, percutaneous
Decision date
1997-07-28
Decision code
APPR
Date received
1997-01-29
Approval order statement
APPROVAL FOR THE ADDITION OF AN ACCESSORY DEVICE, THE FOLIO BALLOON SHAPING TOOL, TO YOUR CURRENTLY MARKETED LINE OF MEDTRONIC (R) MILLENIA(TM) CORONARY BALLOON DILATATION CATHETERS.