|
Device | GRUNTZIG DILACA CORONARY ARTERY BALLOON DILATATION CATHETER |
Generic Name | Catheters, transluminal coronary angioplasty, percutaneous |
Regulation Number | 870.5100 |
Applicant | MEDTRONIC IRELAND Parkmore Business Park West Galway |
PMA Number | P790017 |
Supplement Number | S086 |
Date Received | 12/04/2006 |
Decision Date | 08/17/2007 |
Reclassified Date
|
10/08/2010 |
Product Code |
LOX |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
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. |