|
Device | NC STORMER MX2/OTW 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 | S082 |
Date Received | 04/05/2004 |
Decision Date | 03/04/2005 |
Reclassified Date
|
10/08/2010 |
Product Code |
LOX |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR ADDITION OF THE NC STORMER MX2 CATHETER WITH TWO ADDITIONAL LENGTHS (AS A MODIFIED VERSION OF THE APPROVED NC STORMER MX CATHETER) AND THE ADDITION OF TWO ADDITIONAL LENGTHS FOR THE NC STORMER OTW CATHETER. |