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 | QUANTUM MAVERICK MONORAIL/OTW PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (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 | S182 |
Date Received | 04/16/2002 |
Decision Date | 10/01/2002 |
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 QUANTUM MAVERICK MONORAIL AND OTW PTCA CATHETERS AND APPROVAL FOR AN ADDITIONAL STERILIZATION FACILITY, COSMED OF RI, COVENTRY, RHODE ISLAND. THE QUANTUM MAVERICK MONORAIL & OTW PTCA CATHETERS ARE AVAILABLE IN LENGTHS OF 8, 12, 15, 20 AND 30 MM, WITH DIAMETERS RANGING FROM 2.00 TO 4.00 MM IN 1/4MM INCREMENTS AND 4.5 TO 5.0 MM IN 1/2 MM INCREMENTS (EXCEPT FOR THE 20 MM LENGTH). THE DEVICES, AS MODIFIED, ARE INDICATED FOR BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION AND FOR THE POST DELIVERY EXPANSION OF BALLOON EXPANDABLE STENTS. |
|
|