|
Device | MEDTRONIC(R) MILLENIA (TM) FAMILY OF CORONARY BALLOON DILATATION CATHETERS |
Generic Name | Catheters, transluminal coronary angioplasty, percutaneous |
Regulation Number | 870.5100 |
Applicant | MEDTRONICS INTERVENTIONAL VASCULAR 3576 UNO CAL PLACE SANTA ROSA, CA 95403 |
PMA Number | P870036 |
Supplement Number | S038 |
Date Received | 04/16/1996 |
Decision Date | 09/25/1996 |
Withdrawal Date
|
06/09/2008 |
Product Code |
LOX |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE INTRODUCTION OF A NEW PRODUCT LINE. THE DEVICE AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAME MEDTRONIC MILLENIA CORONARY BALLOON DILATATION CATHETER |