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.
 
DeviceNOVOSTE BETA-CATH SYSTEM
Generic NameIntravascular radiation delivery system
ApplicantBest Vascular, Inc.
4350 International Blvd.
Norcross, GA 30093
PMA NumberP000018
Supplement NumberS037
Date Received09/11/2003
Decision Date10/09/2003
Product Code MOU 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
CHANGE IN THE HYDRAULIC PRESSURE USED IN THE FUNCTIONAL SOURCE TRAIN TRANSPORT INSPECTION OF THE DELIVERY CATHETER.
-
-