|
Device | USCI GRUNTZIG DILACA CORONARY ARTERY BALLOON DILATATION CATHETER & USCI XPRT WITH PRO/PEL COATING BALLOON DILATATION |
Generic Name | Catheters, transluminal coronary angioplasty, percutaneous |
Regulation Number | 870.5100 |
Applicant | MEDTRONIC IRELAND Parkmore Business Park West Galway |
PMA Number | P790017 |
Supplement Number | S057 |
Date Received | 09/20/1995 |
Decision Date | 01/25/1996 |
Reclassified Date
|
10/08/2010 |
Product Code |
LOX |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR REVISED LABELING |