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 CORONARY DILATION CATHETER |
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 | S171 |
Date Received | 12/23/1996 |
Decision Date | 05/12/1997 |
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 |
Approval Order Statement APPROVAL FOR THE ACS RX COMET(TM) CORONARY DILATATION CATHETER WITH THE 40 MM BALLOON LENGTHS WITH THE HALF SIZES (I.E., 2.0 MM, 2.5 MM, 3.0 MM, 3.5 MM, 4.0 MM), THE 15 MM BALLOON LENGTHS WITH THE QUARTER SIZES (I.E., 2.75 MM, 3.25 MM AND 3.75 MM DIAMETERS), THE 30 MM BALLOON LENGTHS (I.E., 2.75 MM, 3.25 MM, 3.75 MM AND 4.0 MM DIAMETERS) AND A SINGLE 20 MM BALLOON LENGTH (I.E., 1.5 MM) AND MODIFICATION OF THE BALLOON COMPLIANCE CHART OF THE ACS RX COMET(TM) CORONARY DILATATION CATHETER TO INLCUDE DATA UP TO 18 ATM FOR BALLOONS WITH A RATED BURST PRESSURE (RBP) OF 14 ATM TO BE CONSISTENT WITH OTHER PTCA MANUFACTURERS. |
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