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.
 
DeviceCELSIUS,CELSIUS II, CELSIUS RMT, EZ STEER, EZ STEER DS DIAGNOSTIC/ABLATION CATHETERS
Generic NameCardiac ablation percutaneous catheter
ApplicantBiosense Webster, Inc
31 Technology Drive
Suite 200
Irvine, CA 92618
PMA NumberP950005
Supplement NumberS021
Date Received07/24/2007
Decision Date08/23/2007
Product Code LPB 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
INCREASING THE STERILIZATION PALLET SIZE FORM A 6-PALLET LOAD TO A 10-PALLET LOAD.
-
-