| 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 | ACS RX COMET VP (TM) CORONARY DILATATION CATHETER/HYDROCOAT HYDROPHILIC |
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| Generic Name | Catheters, transluminal coronary angioplasty, percutaneous |
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| Regulation Number | 870.5100 |
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| Applicant | ADVANCED CARDIOVASCULAR SYSTEMS, INC.
26531 YNEZ RD.
TEMECULA, CA 92591 |
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| PMA Number | P810046 |
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| Supplement Number | S185 |
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| Date Received | 01/20/1998 |
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| Decision Date | 06/08/1998 |
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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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Approval Order Statement
Approval for an additional balloon length, the addition of HYDROCOAT(TM) hydrophilic coating, a change in the sterilization method and hydrophilic coating, a change in the sterilization method and hydrophilic coating, a change in the sterilization method and packaging and an increase in the rated ubrst pressure for the 3.25mm through 4.0mm balloon diameters. The device as modified, will be marketed under the trade name ACS RX Comet VP(TM) Coronary Dilatation Catheters with HYDROCOAT(TM) Hydrophilic coating and is indicated for: 1)balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improvng myocardial perfusion; and 2) balloon dilatation of a coronary artery occlusion for the purose of restoring coronary flow in patients with ST-segment elevation yocardial infarction. |
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