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 3.5F SYSTEM
Generic NameIntravascular radiation delivery system
ApplicantBEST VASCULAR, INC
4350 INTERNATIONAL BOULEVARD
NORCROSS, GA 30093
PMA NumberP000018
Supplement NumberS026
Date Received10/18/2002
Decision Date11/13/2002
Product Code MOU 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR MODIFICATIONS TO THE USER'S MANUAL, USER'S GUIDE AND CUSTOMER TRAINING TO INCLUDE ADDITIONAL INFORMATION ON SCENARIOS WHERE THE BETA-RAIL 3.5F DELIVERY CATHETER TIP MAY BE SUBJECTED TO EXCESSIVE FORCE AND THE TECHNIQUES FOR AVOIDING AND/OR RESOLVING THESE SCENARIOS.
-
-