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 | TX-2000 |
Generic Name | Catheters, transluminal coronary angioplasty, percutaneous |
Regulation Number | 870.5100 |
Applicant | ADVANCED CARDIOVASCULAR SYSTEMS, INC. 26531 YNEZ RD. TEMECULA, CA 92591 |
PMA Number | P810046 |
Supplement Number | S173 |
Date Received | 01/16/1997 |
Decision Date | 04/21/1997 |
Reclassified Date
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10/08/2010 |
Product Code |
LOX |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE ACS TX2000(TM) CORONARY DILATATION CATHETER WITH NEW BALLOON LENGTHS (15 MM AND 40 MM), ADDITIONAL BALLOON DIAMETERS FOR THE 20 MM AND 30 MM BALLOON LENGTHS, AND REVISED LABELING. |
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