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.
 
DeviceGALILEO AND GALILEO III INTRAVASCULAR RADIOTHERAPY SYSTEMS
Generic NameIntravascular radiation delivery system
ApplicantGuidant Corp.
26531 Ynez Rd.
Temecula, CA 92591
PMA NumberP000052
Supplement NumberS009
Date Received07/01/2002
Decision Date12/10/2002
Withdrawal Date01/31/2008
Product Code MOU 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR MODIFICATIONS TO THE CARTRIDGE SHIPPING CONTAINER AND THE ADDITION OF AN ELECTROSTATIC DISCHARGE WARNING LABEL ON THE CARTRIDGE.
-
-