| 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 COYOTE 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 Pl.
Maple Grove, MN 55311 |
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| PMA Number | P860019 |
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| Supplement Number | S146 |
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| Date Received | 06/30/1998 |
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| Decision Date | 08/10/1998 |
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| Reclassified Date | 10/08/2010 |
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| Product Code |
LOX |
| Advisory Committee |
Cardiovascular |
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| Supplement Type | Real-Time Process |
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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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| Predetermined Change Control Plan Authorized | No |
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Approval Order Statement
Approval for the following additional models of the COYOTE(TM) PTCA Catheter: a)the addition of 1/4 mm balloon diameter sizes from 2.25 mm to 3.75 mm for the 20 mm balloon length; b) balloon lengths of 9 mm, 15 mm, and 25 mm in balloon diameters of 2.5 mm to 4.0 mm in 1/4 mm increments; and c) balloon lengths of 20 mm and 40 mm in balloon diameters of 2.0 mm to 4.0 mm in 1/4 mm increments. These PTCA catheter models are indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The 2.5 mm - 5.0 mm balloon models are also indicated for ht epost-delivery expansion of balloon expandable stents. |
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