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. |
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Device | MAVERICK XL PTCA CATHETER (MONORAIL) |
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 | S183 |
Date Received | 05/02/2002 |
Decision Date | 10/24/2002 |
Reclassified Date
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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 MAVERICK XL PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY PTCA) CATHETERS (MONORAIL) AND APPROVAL FOR AN ADDITIONAL STERILIZATION FACILITY, COSMED OF RI, COVENTRY, RHODE ISLAND. THE MAVERICK XL PTCA CATHETERS ARE AVAILABLE IN LENGTHS OF 15 AND 20 MM, WITH DIAMETERS OF 4.0, 4.5, 5.0, 5.5 AND 6.0 MM. THE DEVICES, AS MODIFIED, ARE INDICATED FOR BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION AND FOR THE POST DELIVERY EXPANSION OF BALLOON EXPANDABLE STENTS. |
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