|
Device | BOSTON SCIENTIFIC/SCIMED PTCA/PERFUSION CATHETERS |
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 | S185 |
Date Received | 06/05/2002 |
Decision Date | 06/25/2002 |
Reclassified Date
|
10/08/2010 |
Product Code |
LOX |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE INCLUSION OF A TABLE SPECIFYING THE RECOMMENDED MINIMUM GUIDING CATHETER INNER DIAMETER IN THE INSTRUCTIONS FOR USE (IFU) FOR THE FOLLOWING PTCA CATHETER MODELS: NC MONORAIL, NC RANGER 15 MM, NC RANGER 22/25/30 MM, NC RANGER 16/18 MM AND NC RANGER 9 MM. |