| 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 | CHAMPION WRAP 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 | Progressive Angioplasty Systems, Inc.
1350 Willow Rd.
Suite 201
Menlo Park, CA 94025 |
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| PMA Number | P930012 |
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| Supplement Number | S009 |
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| Date Received | 01/08/1998 |
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| Decision Date | 02/23/1998 |
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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 addition of (1) quarter-size diameter balloons, including sizes of 2.5 mm, 2.75 mm, 3.25 mm, 3.75 mm, 4.25 mm, and 4.5 mm, and (2) a second radiopaque marker to all 20 mm long balloon catheters. The referenced devices are indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. |
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