|
Device | THE MEDTRONIC ACHIEVER CORONARY BALLON DILATION CATHETER |
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 | S044 |
Date Received | 05/20/1998 |
Decision Date | 11/17/1998 |
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 a new product line. The device, as modified, will be marketed under the trade name Medtronic(R) Achiever(TM) Coronary Balloon Dilatation Catheter and is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. |