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 STREAK & ACS FLOW TRACK 40 |
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 | S162 |
Date Received | 04/16/1996 |
Decision Date | 11/05/1996 |
Reclassified Date
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10/08/2010 |
Product Code |
LOX |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE ADDITION OF NEW PRODUCT NAMES TO ALLOW CONCURRENT DISTRIBUTIO BY A SECOND COMPANY. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES ACS RX GAZELLE CORONARY DILATATION CATHETER AND ACS RX FLEXFLO CORONARY DILATATION CATHETER |
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