PMA P870036S041

Device
MEDTRONIC(R) EVERGREEN(TM) CORONARY BALLOON DILATATION CATHETERS
Applicant
Medtronics Interventional Vascular
PMA number
P870036
Supplement
S041
Product code
LOX
Decision date
1997-03-07
Generic name
Catheters, transluminal coronary angioplasty, percutaneous
Approval order statement
APPROVAL FOR A MODIFIED BONDING PROCESS FOR THE RADIOPAQUE MARKER BANDS

Current openFDA PMA Record#

Device
MEDTRONIC(R) EVERGREEN(TM) CORONARY BALLOON DILATATION CATHETERS
Applicant
Medtronics Interventional Vascular
PMA number
P870036
Supplement
S041
Product code
LOX
Generic name
Catheters, transluminal coronary angioplasty, percutaneous
Decision date
1997-03-07
Decision code
APPR
Date received
1996-11-21
Supplement type
Normal 180 Day Track
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
APPROVAL FOR A MODIFIED BONDING PROCESS FOR THE RADIOPAQUE MARKER BANDS