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 VP CORONARY DILATATION CATHETER (OTHER DILATATION CATHETERS)
Generic NameCatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
ApplicantADVANCED CARDIOVASCULAR SYSTEMS, INC.
26531 YNEZ RD.
TEMECULA, CA 92591
PMA NumberP810046
Supplement NumberS196
Date Received12/22/1998
Decision Date01/22/1999
Reclassified Date 10/08/2010
Product Code LOX 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the implementation of an additional quality control inspection to further ensure that hte balloon size designation on the proximal adaptor is correct fo rthe ACS RX Comet VP(TM) Coronary Dilatation Catheter and the other ACS Coronary Dilatation Catheters listed in the supplement.
-
-