|
Device | NC QUANTUM APEX MONORAIL AND OVER-THE-WIRE PTCA 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 | S241 |
Date Received | 09/04/2009 |
Decision Date | 04/16/2010 |
Reclassified Date
|
10/08/2010 |
Product Code |
LOX |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR: 1) A NEW BALLOON AND MARKERBAND MATERIALS; 2) EXTENSION OF THE PRODUCT MATRIX TO INCLUDE A 6MM LENGTH; 3) AN ALTERNATE BOND FOR MONORAIL MODELS; AND 4) A CHANGE IN THE HYDROPHILIC COATING LENGTH ON OVER-THE-WIRE MODELS. |