|
Device | SCIMED WAVE PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) |
Generic Name | Catheters, transluminal coronary angioplasty, percutaneous |
Regulation Number | 870.5100 |
Applicant | SCIMED LIFE SYSTEMS, INC. ONE SCIMED PLACE MAPLE GROVE, MN 55311-1566 |
PMA Number | P860019 |
Supplement Number | S108 |
Date Received | 11/01/1995 |
Decision Date | 06/10/1996 |
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 |
Approval Order Statement APPROVAL FOR THE SCIMED WAVE PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) PERFUSION CATHETER. THE DEVICE AS MODIFIED WILL BE MARKETED FOR THE BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION |