PMA P790017S109

Device
GRUNTZIG DILACA BALLOON DILATATION CATHETERS
Applicant
Medtronic, Ireland
PMA number
P790017
Supplement
S109
Product code
LOX
Decision date
2010-09-14
Generic name
Catheters, transluminal coronary angioplasty, percutaneous
Approval order statement
ALTERNATE SYSTEM FOR MEASURING EXTRUDED TUBING.

Current openFDA PMA Record#

Device
GRUNTZIG DILACA BALLOON DILATATION CATHETERS
Applicant
Medtronic, Ireland
PMA number
P790017
Supplement
S109
Product code
LOX
Generic name
Catheters, transluminal coronary angioplasty, percutaneous
Decision date
2010-09-14
Decision code
OK30
Date received
2010-08-16
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
ALTERNATE SYSTEM FOR MEASURING EXTRUDED TUBING.