|
Device | GRUNTZIG DILACA BALLOON DILATATION CATHETERS |
Generic Name | Catheters, transluminal coronary angioplasty, percutaneous |
Regulation Number | 870.5100 |
Applicant | MEDTRONIC IRELAND Parkmore Business Park West Galway |
PMA Number | P790017 |
Supplement Number | S109 |
Date Received | 08/16/2010 |
Decision Date | 09/14/2010 |
Reclassified Date
|
10/08/2010 |
Product Code |
LOX |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement ALTERNATE SYSTEM FOR MEASURING EXTRUDED TUBING. |