• 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.
 
DeviceGALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM
Classification Nameintravascular radiation delivery system
Generic Nameintravascular radiation delivery system
Applicant
GUIDANT CORP.
26531 ynez rd.
temecula, CA 92591-4630
PMA NumberP000052
Supplement NumberS024
Date Received04/06/2004
Decision Date05/04/2004
Product Code
MOU[ Registered Establishments with MOU ]
Advisory Committee Cardiovascular
Supplement Typespecial (immediate track)
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR THE ADDITION OF A SECONDARY WIPE STATION TO THE MANUFACTURING PROCESS FOR THE GDT-P32-1 SOURCE WIRES.
-
-