| 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 | SCIMED NC MAXXUM PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER |
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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 | S150 |
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| Date Received | 10/05/1998 |
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| Decision Date | 04/08/1999 |
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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 SCIMED NC MAXXUM(TM) PTCA Catheter (20mm balloon length with balloon diameters of 2.0mm, 2.5-4.0mm in 1/4mm increments and 4.5mm, -5.0mm in 1/2mm increments; and 9mm and 15mm lengths with balloon diameterrs of 2.5-4.0mm in 1/4mm increments and 4.5mm - 5.0mm) in 1/2mm increments. The NC MAXXUM(TM) PTCA Catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or byapss graft stenosis for th epurpose of improving myocardial perfusion. The NC MAXUUM(TM) PTCA Catheter (balloon models 2.5-4.0mm in diameter) is also indicated for the post-delivery expansion of balloon expandable stents. |
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