Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
|
Device | VOYAGER RX CORONARY DILATATION CATHETER |
Generic Name | Catheters, transluminal coronary angioplasty, percutaneous |
Regulation Number | 870.5100 |
Applicant | ADVANCED CARDIOVASCULAR SYSTEMS, INC. 26531 YNEZ RD. TEMECULA, CA 92591 |
PMA Number | P810046 |
Supplement Number | S216 |
Date Received | 03/08/2004 |
Decision Date | 06/18/2004 |
Reclassified Date
|
10/08/2010 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE VOYAGER RX CORONARY DILATATION CATHETER. THE DEVICE, AS MODIFIED, IS INDICATED FOR 1) BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION, 2) BALLOON DILATATION OF A CORONARY OCCLUSION FOR THE PURPOSE OF RESTORING CORONARY FLOW IN PATIENTS WITH ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION, AND 3) BALLOON DILATATION OF STENT AFTER IMPLANTATION (TESTING INCLUDING THE FOLLOWING GUIDANT STENTS: MULTI-LINK: PIXEL AND PENTA AND ZETA CORONARY STENT SYSTEMS). |
|
|