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 |
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 | S146 |
Date Received | 06/30/1998 |
Decision Date | 08/10/1998 |
Reclassified Date
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10/08/2010 |
Product Code |
LOX |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
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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