| 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 | QUANTUM MAVERICK MONORAIL/OTW PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETERS |
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| Generic Name | Catheters, transluminal coronary angioplasty, percutaneous |
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| Regulation Number | 870.5100 |
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| Applicant | SCIMED LIFE SYSTEMS, INC.
ONE SCIMED PLACE
MAPLE GROVE, MN 55311-1566 |
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| PMA Number | P860019 |
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| Supplement Number | S182 |
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| Date Received | 04/16/2002 |
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| Decision Date | 10/01/2002 |
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Reclassified Date
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10/08/2010 |
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| Product Code |
LOX |
| Advisory Committee |
Cardiovascular |
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| Supplement Type | Normal 180 Day Track |
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| Supplement Reason | Change Design/Components/Specifications/Material |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Recalls | CDRH Recalls |
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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. |
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