PMA P790017S086

Device: GRUNTZIG DILACA CORONARY ARTERY BALLOON DILATATION CATHETER
Applicant: Medtronic, Ireland
PMA number: P790017
Supplement: S086
Product code: LOX
Decision date: 2007-08-17
Classification: Catheters, Transluminal Coronary Angioplasty, Percutaneous
Generic name: Catheters, transluminal coronary angioplasty, percutaneous
Approval order statement: APPROVAL TO: 1) INTRODUCE AN AUTOMATED INFLATION DEVICE, REPLACING THE CURRENT MANUAL PROCESS, TO INFLATE PTCA BALLOONS PRIOR TO IN-PROCESS FUNCTIONAL TESTING; AND 2) REDUCE THE NUMBER OF SAMPLES WHICH ARE TAKEN TO MONITOR PARTICULATE LEVELS IN NITROGEN GAS AND COMPRESSED AIR.

Current openFDA PMA Record#

Device: GRUNTZIG DILACA CORONARY ARTERY BALLOON DILATATION CATHETER
Applicant: Medtronic, Ireland
PMA number: P790017
Supplement: S086
Product code: LOX
Generic name: Catheters, transluminal coronary angioplasty, percutaneous
Decision date: 2007-08-17
Decision code: APPR
Date received: 2006-12-04
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL TO: 1) INTRODUCE AN AUTOMATED INFLATION DEVICE, REPLACING THE CURRENT MANUAL PROCESS, TO INFLATE PTCA BALLOONS PRIOR TO IN-PROCESS FUNCTIONAL TESTING; AND 2) REDUCE THE NUMBER OF SAMPLES WHICH ARE TAKEN TO MONITOR PARTICULATE LEVELS IN NITROGEN GAS AND COMPRESSED AIR.