Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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.
 
DeviceACS RX COMET CORONARY DILATION CATHETER
Generic NameCatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
ApplicantADVANCED CARDIOVASCULAR SYSTEMS, INC.
26531 YNEZ RD.
TEMECULA, CA 92591
PMA NumberP810046
Supplement NumberS171
Date Received12/23/1996
Decision Date05/12/1997
Reclassified Date 10/08/2010
Product Code LOX 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
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.
-
-